Stapling assembly components having metal substrates and plastic bodies

ABSTRACT

A surgical stapling assembly is disclosed. The surgical stapling assembly can include a first jaw, a second jaw, an articulation joint, a closure drive comprising a first flexible rotary drive extending through the articulation joint, and a firing drive comprising a second flexible rotary drive extending through the articulation joint and rotatable independent of the first flexible rotary drive. The surgical stapling assembly can further include a 3D-printed component. The 3D-printed component can include a plastic body and one or more metal substrates with interlocking features embedded in the plastic body. The surgical stapling assembly can include a firing member having a flexible portion configured to flex more readily that adjacent portions of the firing member.

BACKGROUND

The present invention relates to surgical instruments and, in variousarrangements, to surgical stapling and cutting instruments, endeffectors, and staple cartridges for use therewith that are designed tostaple and cut tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of the embodiments described herein, together withadvantages thereof, may be understood in accordance with the followingdescription taken in conjunction with the accompanying drawings asfollows:

FIG. 1 is a perspective view of a surgical stapling instrumentcomprising a handle, a shaft assembly, and an end effector, inaccordance with at least one aspect of the present disclosure.

FIG. 2 is a perspective view of the end effector and a portion of theshaft assembly of the surgical stapling instrument of FIG. 1, whereinthe end effector is illustrated in a straight, or non-articulated,configuration, in accordance with at least one aspect of the presentdisclosure.

FIG. 3 is a perspective view of the end effector and a portion of theshaft assembly of the surgical stapling instrument of FIG. 1, whereinthe end effector is illustrated in an articulated configuration, inaccordance with at least one aspect of the present disclosure.

FIG. 4 is an exploded perspective view of the end effector and a portionof the shaft assembly of the surgical stapling instrument of FIG. 1, inaccordance with at least one aspect of the present disclosure.

FIG. 5 is a cross-sectional elevation view of the end effector and aportion of the shaft assembly of the surgical stapling instrument ofFIG. 1, wherein the end effector is illustrated in an unfired, clampedconfiguration, in accordance with at least one aspect of the presentdisclosure.

FIG. 6 is a plan view of the end effector and a portion of the shaftassembly of the surgical stapling instrument of FIG. 1, in accordancewith at least one aspect of the present disclosure.

FIG. 7 is a cross-sectional elevation view of the end effector and aportion of the shaft assembly of FIG. 1 taken along section line 6-6 inFIG. 6, wherein the end effector is illustrated in an openconfiguration, in accordance with at least one aspect of the presentdisclosure.

FIG. 8 is a cross-sectional elevation view of the end effector and aportion of the shaft assembly of FIG. 1 taken along section line 7-7 inFIG. 6, wherein the end effector is illustrated in a clampedconfiguration, in accordance with at least one aspect of the presentdisclosure.

FIG. 9 is a perspective view of a surgical stapling assembly comprisinga shaft assembly and the end effector of FIG. 1, wherein the endeffector is attached to the shaft assembly by way of an articulationjoint, in accordance with at least one aspect of the present disclosure.

FIG. 10 is an exploded perspective view of the surgical staplingassembly of FIG. 9, in accordance with at least one aspect of thepresent disclosure.

FIG. 11 is a cross-sectional elevation view of the surgical staplingassembly of FIG. 9, wherein the end effector is illustrated in anunfired, clamped configuration, in accordance with at least one aspectof the present disclosure.

FIG. 12 is a perspective view of a surgical stapling assembly comprisinga shaft assembly and the end effector of FIG. 1, wherein the endeffector is attached to the shaft assembly by way of an articulationjoint, in accordance with at least one aspect of the present disclosure.

FIG. 13 is an exploded perspective view of the surgical staplingassembly of FIG. 12, in accordance with at least one aspect of thepresent disclosure.

FIG. 14 is a cross-sectional elevation view of the surgical staplingassembly of FIG. 12, wherein the end effector is illustrated in anunfired, clamped configuration, in accordance with at least one aspectof the present disclosure.

FIG. 15 is a perspective view of a surgical stapling assembly comprisinga shaft assembly and the end effector of FIG. 1, wherein the endeffector is attached to the shaft assembly by way of an articulationjoint, in accordance with at least one aspect of the present disclosure.

FIG. 16 is an exploded perspective view of the surgical staplingassembly of FIG. 15, in accordance with at least one aspect of thepresent disclosure.

FIG. 17 is a cross-sectional elevation view of the surgical staplingassembly of FIG. 15, wherein the end effector is illustrated in anunfired, clamped configuration, in accordance with at least one aspectof the present disclosure.

FIG. 18 is a perspective view of a surgical end effector assemblycomprising the end effector of FIG. 1 and a flexible firing drivesystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 19 is an exploded perspective view of the surgical staplingassembly of FIG. 18, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a cross-sectional elevation view of the surgical end effectorassembly of FIG. 18, wherein the surgical end effector assembly isillustrated in an unfired, clamped configuration, in accordance with atleast one aspect of the present disclosure.

FIG. 21 is a perspective view of robotic controller, in accordance withat least one aspect of the present disclosure.

FIG. 22 is a perspective view of a robotic arm cart for a roboticsurgical system, depicting manipulators on the robotic arm cart operablysupporting surgical tools, in accordance with at least one aspect of thepresent disclosure.

FIG. 23 is a side view of a manipulator of the surgical arm cart of FIG.22 and a surgical grasping tool, in accordance with at least one aspectof the present disclosure.

FIG. 24 is a side elevation view of a firing member, according tovarious aspects of the present disclosure.

FIG. 25 is a side elevation view of the firing member of FIG. 24 in anexpanded configuration, according to various aspects of the presentdisclosure.

FIG. 26 is an elevation cross-section view of a portion of a surgicalinstrument including an expandable knife portion, according to variousaspects of the present disclosure.

FIG. 27 is a perspective view of a surgical instrument including ananvil having a low durometer material, depicting the surgical instrumentin an open configuration, according to various aspects of the presentdisclosure.

FIG. 28 is an elevation cross-section view of the surgical instrument ofFIG. 27, depicting the surgical instrument in a closed configuration,according to various aspects of the present disclosure.

FIG. 29 is a perspective view of a firing member for use with a surgicalinstrument, according to various aspects of the present disclosure.

FIG. 30 is an enlarged view of a portion of the firing member of FIG.29, according to various aspects of the present disclosure.

FIG. 31 is a perspective partial cross-section view of a portion of thefiring member of FIG. 29, according to various aspects of the presentdisclosure.

FIG. 32 is a side elevation view of a firing member for use with asurgical instrument, depicting the firing member in a firstconfiguration, according to various aspects of the present disclosure.

FIG. 33 is a side elevation view of the firing member of FIG. 32 in asecond configuration in which the firing member is deformed from thefirst configuration to a loaded configuration and depicting portions ofa channel and an anvil with dashed lines for environmental structure,according to various aspects of the present disclosure.

FIG. 34 is a perspective view of a firing member for use with a surgicalinstrument, according to various aspects of the present disclosure.

FIG. 35 is a side elevation view of the firing member of FIG. 34,according to various aspects of the present disclosure.

FIG. 36 is a front elevation view of the firing member of FIG. 34,according to various aspects of the present disclosure.

FIG. 37 is a graphical representation of exemplary forces imparted onthe firing member of FIG. 34 during a firing stroke, according tovarious aspects of the present disclosure.

FIG. 38 is a perspective view of a firing member for use with a surgicalinstrument, according to various aspects of the present disclosure.

FIG. 39 is a side elevation view of the firing member of FIG. 38,according to various aspects of the present disclosure.

FIG. 40 is a perspective view of a model structure before force loadingshown in phantom lines and during force loading shown with solid lines,according to various aspects of the present disclosure.

FIG. 41 is an elevation view of a channel retainer having substrateportions, according to various aspects of the present disclosure.

FIG. 42 is a perspective exploded view of a portion of the substrateelements of FIG. 41, according to various aspects of the presentdisclosure.

FIG. 43 is an elevation cross-section view of the channel retainer ofFIG. 41 taken along the plane indicated in FIG. 41, according to variousaspects of the present disclosure.

FIG. 44 is a perspective view of a portion of a surgical instrumentcomprising an over-molded sleeve depicted with phantom lines, andfurther depicting a firing bar support within the over-molded sleeve,according to various aspects of the present disclosure.

FIG. 45 is a plan view of the portion of the surgical instrument of FIG.44 depicted with phantom lines for the over-molded sleeve, and furtherdepicting the instrument in an articulated configuration, according tovarious aspects of the present disclosure.

FIG. 46 is an elevation cross-section view of an anvil for use with asurgical instrument, according to various aspects of the presentdisclosure.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications that were filed on even date herewith and which are eachherein incorporated by reference in their respective entireties:

-   -   U.S. Patent Application entitled METHOD OF USING A POWERED        STAPLING DEVICE, Attorney Docket No. END9298USNP1/200859-1M;    -   U.S. Patent Application entitled SURGICAL STAPLING ASSEMBLY        COMPRISING NONPLANAR STAPLES AND PLANAR STAPLES, Attorney Docket        No. END9298USNP2/200859-2;    -   U.S. Patent Application entitled SURGICAL STAPLE CARTRIDGE        COMPRISING LONGITUDINAL SUPPORT BEAM, Attorney Docket No.        END9298USNP3/200859-3;    -   U.S. Patent Application entitled ROTARY-DRIVEN SURGICAL STAPLING        ASSEMBLY COMPRISING ECCENTRICALLY DRIVEN FIRING MEMBER, Attorney        Docket No. END9298USNP4/200859-4;    -   U.S. Patent Application entitled ROTARY-DRIVEN SURGICAL STAPLING        ASSEMBLY COMPRISING A FLOATABLE COMPONENT, Attorney Docket No.        END9298USNP5/200859-5;    -   U.S. Patent Application entitled DRIVERS FOR FASTENER CARTRIDGE        ASSEMBLIES HAVING ROTARY DRIVE SCREWS, Attorney Docket No.        END9298USNP6/200859-6;    -   U.S. Patent Application entitled MATING FEATURES BETWEEN DRIVERS        AND UNDERSIDE OF A CARTRIDGE DECK, attorney Docket No.        END9298USNP7/200859-7;    -   U.S. Patent Application entitled LEVERAGING SURFACES FOR        CARTRIDGE INSTALLATION, Attorney Docket No.        END9298USNP8/200859-8;    -   U.S. Patent Application entitled FASTENER CARTRIDGE WITH        NON-REPEATING FASTENER ROWS, Attorney Docket No.        END9298USNP9/200859-9;    -   U.S. Patent Application entitled FIRING MEMBERS HAVING FLEXIBLE        PORTIONS FOR ADAPTING TO A LOAD DURING A SURGICAL FIRING STROKE,        Attorney Docket No. END9298USNP10/200859-10;    -   U.S. Patent Application entitled MULTI-AXIS PIVOT JOINTS FOR        SURGICAL INSTRUMENTS AND METHODS OF MANUFACTURING SAME, Attorney        Docket No. END9298USNP12/200859-12;    -   U.S. Patent Application entitled JOINT ARRANGEMENTS FOR        MULTI-PLANAR ALIGNMENT AND SUPPORT OF OPERATIONAL DRIVE SHAFTS        IN ARTICULATABLE SURGICAL INSTRUMENTS, Attorney Docket No.        END9298USNP13/200859-13; and    -   U.S. Patent Application entitled SURGICAL INSTRUMENT        ARTICULATION JOINT ARRANGEMENTS COMPRISING MULTIPLE MOVING        LINKAGE FEATURES, Attorney Docket No. END9298USNP14/200859-14.

Applicant of the present application owns the following U.S. PatentApplications and U.S. Patents that were filed on Dec. 19, 2017 and whichare each herein incorporated by reference in their respectiveentireties:

-   -   U.S. Pat. No. 10,835,330, entitled METHOD FOR DETERMINING THE        POSITION OF A ROTATABLE JAW OF A SURGICAL INSTRUMENT ATTACHMENT        ASSEMBLY;    -   U.S. Pat. No. 10,716,565, entitled SURGICAL INSTRUMENTS WITH        DUAL ARTICULATION DRIVES;    -   U.S. patent application Ser. No. 15/847,325, entitled SURGICAL        TOOLS CONFIGURED FOR INTERCHANGEABLE USE WITH DIFFERENT        CONTROLLER INTERFACES, now U.S. Patent Application Publication        No. 2019/0183491;    -   U.S. Pat. No. 10,729,509 entitled SURGICAL INSTRUMENT COMPRISING        CLOSURE AND FIRING LOCKING MECHANISM;    -   U.S. patent application Ser. No. 15/847,315, entitled ROBOTIC        ATTACHMENT COMPRISING EXTERIOR DRIVE ACTUATOR, now U.S. Patent        Application Publication No. 2019/0183594; and    -   U.S. Design Pat. No. D910,847, entitled SURGICAL INSTRUMENT        ASSEMBLY.

Applicant of the present application owns the following U.S. PatentApplications and U.S. Patents that were filed on Jun. 28, 2017 and whichare each herein incorporated by reference in their respectiveentireties:

-   -   U.S. patent application Ser. No. 15/635,693, entitled SURGICAL        INSTRUMENT COMPRISING AN OFFSET ARTICULATION JOINT, now U.S.        Patent Application Publication No. 2019/0000466;    -   U.S. patent application Ser. No. 15/635,729, entitled SURGICAL        INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO, now U.S.        Patent Application Publication No. 2019/0000467;    -   U.S. patent application Ser. No. 15/635,785, entitled SURGICAL        INSTRUMENT COMPRISING AN ARTICULATION SYSTEM RATIO, now U.S.        Patent Application Publication No. 2019/0000469;    -   U.S. patent application Ser. No. 15/635,808, entitled SURGICAL        INSTRUMENT COMPRISING FIRING MEMBER SUPPORTS, now U.S. Patent        Application Publication No. 2019/0000471;    -   U.S. patent application Ser. No. 15/635,837, entitled SURGICAL        INSTRUMENT COMPRISING AN ARTICULATION SYSTEM LOCKABLE TO A        FRAME, now U.S. Patent Application Publication No. 2019/0000472;    -   U.S. Pat. No. 10,779,824, entitled SURGICAL INSTRUMENT        COMPRISING AN ARTICULATION SYSTEM LOCKABLE BY A CLOSURE SYSTEM;    -   U.S. patent application Ser. No. 15/636,029, entitled SURGICAL        INSTRUMENT COMPRISING A SHAFT INCLUDING A HOUSING ARRANGEMENT,        now U.S. Patent Application Publication No. 2019/0000477;    -   U.S. patent application Ser. No. 15/635,958, entitled SURGICAL        INSTRUMENT COMPRISING SELECTIVELY ACTUATABLE ROTATABLE COUPLERS,        now U.S. Patent Application Publication No. 2019/0000474;    -   U.S. patent application Ser. No. 15/635,981, entitled SURGICAL        STAPLING INSTRUMENTS COMPRISING SHORTENED STAPLE CARTRIDGE        NOSES, now U.S. Patent Application Publication No. 2019/0000475;    -   U.S. patent application Ser. No. 15/636,009, entitled SURGICAL        INSTRUMENT COMPRISING A SHAFT INCLUDING A CLOSURE TUBE PROFILE,        now U.S. Patent Application Publication No. 2019/0000476;    -   U.S. Pat. No. 10,765,427, entitled METHOD FOR ARTICULATING A        SURGICAL INSTRUMENT;    -   U.S. patent application Ser. No. 15/635,530, entitled SURGICAL        INSTRUMENTS WITH ARTICULATABLE END EFFECTOR WITH AXIALLY        SHORTENED ARTICULATION JOINT CONFIGURATIONS, now U.S. Patent        Application Publication No. 2019/0000457;    -   U.S. Pat. No. 10,588,633, entitled SURGICAL INSTRUMENTS WITH        OPEN AND CLOSABLE JAWS AND AXIALLY MOVABLE FIRING MEMBER THAT IS        INITIALLY PARKED IN CLOSE PROXIMITY TO THE JAWS PRIOR TO FIRING;    -   U.S. patent application Ser. No. 15/635,559, entitled SURGICAL        INSTRUMENTS WITH JAWS CONSTRAINED TO PIVOT ABOUT AN AXIS UPON        CONTACT WITH A CLOSURE MEMBER THAT IS PARKED IN CLOSE PROXIMITY        TO THE PIVOT AXIS, now U.S. Patent Application Publication No.        2019/0000459;    -   U.S. Pat. No. 10,786,253, entitled SURGICAL END EFFECTORS WITH        IMPROVED JAW APERTURE ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/635,594, entitled SURGICAL        CUTTING AND FASTENING DEVICES WITH PIVOTABLE ANVIL WITH A TISSUE        LOCATING ARRANGEMENT IN CLOSE PROXIMITY TO AN ANVIL PIVOT AXIS,        now U.S. Patent Application Publication No. 2019/0000461;    -   U.S. patent application Ser. No. 15/635,612, entitled JAW        RETAINER ARRANGEMENT FOR RETAINING A PIVOTABLE SURGICAL        INSTRUMENT JAW IN PIVOTABLE RETAINING ENGAGEMENT WITH A SECOND        SURGICAL INSTRUMENT JAW, now U.S. Patent Application Publication        No. 2019/0000462;    -   U.S. Pat. No. 10,758,232, entitled SURGICAL INSTRUMENT WITH        POSITIVE JAW OPENING FEATURES;    -   U.S. Pat. No. 10,639,037, entitled SURGICAL INSTRUMENT WITH        AXIALLY MOVABLE CLOSURE MEMBER;    -   U.S. Pat. No. 10,695,057, entitled SURGICAL INSTRUMENT LOCKOUT        ARRANGEMENT; U.S. Design Pat. No. D851,762, entitled ANVIL;    -   U.S. Design Pat. No. D854,151, entitled SURGICAL INSTRUMENT        SHAFT; and    -   U.S. Design Pat. No. D869,655, entitled SURGICAL FASTENER        CARTRIDGE.

Applicant of the present application owns the following U.S. PatentApplications and U.S. Patents that were filed on Jun. 27, 2017 and whichare each herein incorporated by reference in their respectiveentireties:

-   -   U.S. patent application Ser. No. 15/634,024, entitled SURGICAL        ANVIL MANUFACTURING METHODS, now U.S. Patent Application        Publication No. 2018/0368839;    -   U.S. Pat. No. 10,772,629, entitled SURGICAL ANVIL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/634,046, entitled SURGICAL        ANVIL ARRANGEMENTS, now U.S. Patent Application Publication No.        2018/0368841;    -   U.S. Pat. No. 10,856,869, entitled SURGICAL ANVIL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/634,068, entitled SURGICAL        FIRING MEMBER ARRANGEMENTS, now U.S. Patent Application        Publication No. 2018/0368843;    -   U.S. patent application Ser. No. 15/634,076, entitled STAPLE        FORMING POCKET ARRANGEMENTS, now U.S. Patent Application        Publication No. 2018/0368844;    -   U.S. patent application Ser. No. 15/634,090, entitled STAPLE        FORMING POCKET ARRANGEMENTS, now U.S. Patent Application        Publication No. 2018/0368845;    -   U.S. patent application Ser. No. 15/634,099, entitled SURGICAL        END EFFECTORS AND ANVILS, now U.S. Patent Application        Publication No. 2018/0368846; and    -   U.S. Pat. No. 10,631,859, entitled ARTICULATION SYSTEMS FOR        SURGICAL INSTRUMENTS.

Applicant of the present application owns the following U.S. PatentApplications that were filed on Jun. 2, 2020 and which are each hereinincorporated by reference in their respective entireties:

-   -   U.S. Design patent application Ser. No. 29/736,648, entitled        STAPLE CARTRIDGE;    -   U.S. Design patent application Ser. No. 29/736,649, entitled        STAPLE CARTRIDGE;    -   U.S. Design patent application Ser. No. 29/736,651, entitled        STAPLE CARTRIDGE;    -   U.S. Design patent application Ser. No. 29/736,652, entitled        STAPLE CARTRIDGE;    -   U.S. Design patent application Ser. No. 29/736,653, entitled        STAPLE CARTRIDGE;    -   U.S. Design patent application Ser. No. 29/736,654, entitled        STAPLE CARTRIDGE; and    -   U.S. Design patent application Ser. No. 29/736,655, entitled        STAPLE CARTRIDGE.

Applicant of the present application owns the following U.S. DesignPatent Applications and U.S. Patents that were filed on Nov. 14, 2016,and which are each herein incorporated by reference in their respectiveentireties:

-   -   U.S. patent application Ser. No. 15/350,621, now U.S. Patent        Application Publication No. 2018/0132849, entitled STAPLE        FORMING POCKET CONFIGURATIONS FOR CIRCULAR STAPLER ANVIL;    -   U.S. patent application Ser. No. 15/350,624, now U.S. Patent        Application Publication No. 2018/0132854, entitled CIRCULAR        SURGICAL STAPLER WITH ANGULARLY ASYMMETRIC DECK FEATURES;    -   U.S. Design Pat. No. D833,608, titled STAPLING HEAD FEATURE FOR        SURGICAL STAPLER; and    -   U.S. Design Pat. No. D830,550, titled SURGICAL STAPLER.

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. Well-known operations, components, andelements have not been described in detail so as not to obscure theembodiments described in the specification. The reader will understandthat the embodiments described and illustrated herein are non-limitingexamples, and thus it can be appreciated that the specific structuraland functional details disclosed herein may be representative andillustrative. Variations and changes thereto may be made withoutdeparting from the scope of the claims.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a surgicalsystem, device, or apparatus that “comprises,” “has,” “includes” or“contains” one or more elements possesses those one or more elements,but is not limited to possessing only those one or more elements.Likewise, an element of a system, device, or apparatus that “comprises,”“has,” “includes” or “contains” one or more features possesses those oneor more features, but is not limited to possessing only those one ormore features.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical device. Theterm “proximal” refers to the portion closest to the clinician and theterm “distal” refers to the portion located away from the clinician. Itwill be further appreciated that, for convenience and clarity, spatialterms such as “vertical”, “horizontal”, “up”, and “down” may be usedherein with respect to the drawings. However, surgical device are usedin many orientations and positions, and these terms are not intended tobe limiting and/or absolute. In the following description, terms such as“first,” “second,” “top,” “bottom,” “up,” “down,” and the like are wordsof convenience and are not to be construed as limiting terms.

References to items in the singular should be understood to includeitems in the plural, and vice versa, unless explicitly stated otherwiseor clear from the text. Grammatical conjunctions are intended to expressany and all disjunctive and conjunctive combinations of conjoinedclauses, sentences, words, and the like, unless otherwise stated orclear from the context. Thus, the term “or” should generally beunderstood to mean “and/or”, etc.

Recitation of ranges of values herein are not intended to be limiting,referring instead individually to any and all values falling within therange, unless otherwise indicated herein, and each separate value withinsuch a range is incorporated into the disclosure as if it wereindividually recited herein. The words “about,” “approximately” or thelike, when accompanying a numerical value, are to be construed asindicating a deviation as would be appreciated by one of ordinary skillin the art to operate satisfactorily for an intended purpose. Similarly,words of approximation such as “approximately” or “substantially” whenused in reference to physical characteristics, should be construed tocontemplate a range of deviations that would be appreciated by one ofordinary skill in the art to operate satisfactorily for a correspondinguse, function, purpose or the like.

The use of any and all examples, or exemplary language (“e.g.,” “suchas,” or the like) provided herein, is intended merely to betterilluminate the embodiments and does not pose a limitation on the scopeof the embodiments. No language in the specification should be construedas indicating any unclaimed element as essential to the practice of theembodiments.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, thereader will readily appreciate that the various methods and devicesdisclosed herein can be used in numerous surgical procedures andapplications including, for example, in connection with open surgicalprocedures. As the present Detailed Description proceeds, the readerwill further appreciate that the various surgical devices disclosedherein can be inserted into a body in any way, such as through a naturalorifice, through an incision or puncture hole formed in tissue, etc. Theworking portions or end effector portions of the surgical devices can beinserted directly into a patient's body or can be inserted through anaccess device that has a working channel through which the end effectorand elongate shaft of a surgical device can be advanced.

A surgical stapling system can comprise a shaft and an end effectorextending from the shaft. The end effector comprises a first jaw and asecond jaw. The first jaw comprises a staple cartridge. The staplecartridge is insertable into and removable from the first jaw; however,other embodiments are envisioned in which a staple cartridge is notremovable from, or at least readily replaceable from, the first jaw. Thesecond jaw comprises an anvil configured to deform staples ejected fromthe staple cartridge. The second jaw is pivotable relative to the firstjaw about a closure axis; however, other embodiments are envisioned inwhich the first jaw is pivotable relative to the second jaw. Thesurgical stapling system further comprises an articulation jointconfigured to permit the end effector to be rotated, or articulated,relative to the shaft. The end effector is rotatable about anarticulation axis extending through the articulation joint. Otherembodiments are envisioned which do not include an articulation joint.

The staple cartridge comprises a cartridge body. The cartridge bodyincludes a proximal end, a distal end, and a deck extending between theproximal end and the distal end. In use, the staple cartridge ispositioned on a first side of the tissue to be stapled and the anvil ispositioned on a second side of the tissue to be stapled. The anvil ismoved toward the staple cartridge to compress and clamp the tissueagainst the deck. Thereafter, staples removably stored in the cartridgebody can be deployed into the tissue. The cartridge body includes staplecavities defined therein wherein staples are removably stored in thestaple cavities. The staple cavities are arranged in six longitudinalrows. Three rows of staple cavities are positioned on a first side of alongitudinal slot and three rows of staple cavities are positioned on asecond side of the longitudinal slot. Other arrangements of staplecavities and staples are contemplated.

The staples are supported by staple drivers in the cartridge body. Thedrivers are movable between a first, or unfired, position and a second,or fired, position to eject the staples from the staple cavities. Thedrivers are retained in the cartridge body by a retainer which extendsaround the bottom of the cartridge body and includes resilient membersconfigured to grip the cartridge body and hold the retainer to thecartridge body. The drivers are movable between their unfired positionsand their fired positions by a sled. The sled is movable between aproximal position adjacent a proximal end of the cartridge body and adistal position adjacent a distal end of the cartridge body. The sledcomprises a plurality of ramped surfaces configured to slide under thedrivers and lift the drivers, and the staples supported thereon, towardthe anvil.

Further to the above, the sled is moved distally by a firing member. Thefiring member is configured to contact the sled and push the sled towardthe distal end. The longitudinal slot defined in the cartridge body isconfigured to receive the firing member. The anvil also includes a slotconfigured to receive the firing member. The firing member furthercomprises a first cam which engages the first jaw and a second cam whichengages the second jaw. As the firing member is advanced distally, thefirst cam and the second cam can control the distance, or tissue gap,between the deck of the staple cartridge and the anvil. The firingmember also comprises a knife configured to incise the tissue capturedintermediate the staple cartridge and the anvil. It is desirable for theknife to be positioned at least partially proximal to the rampedsurfaces such that the staples are ejected into the tissue ahead of theknife transecting the tissue.

FIGS. 1-8 depict a surgical stapling instrument 10 configured to clamp,staple, and cut tissue of a patient. The surgical stapling instrument 10comprises a handle 20, a shaft assembly 100 attached to the handle 20,and an end effector 200. To cut and staple tissue of a patient, the endeffector 200 comprises a cartridge jaw 201 and an anvil jaw 203. Theanvil jaw 203 is pivotable relative to the cartridge jaw 203 to clamptissue between the anvil jaw 203 and the cartridge jaw 203. Once tissueis clamped between the jaws 201, 203, the surgical stapling instrument10 may be actuated to advance a firing member through the jaws 201, 203to staple and cut tissue with the end effector 200 as discussed ingreater detail below.

Discussed in greater detail below, the end effector 200 is articulatableby way of an articulation region 110 of the shaft assembly 100. Sucharticulation provides a user of the surgical stapling instrument 10 withthe ability to position and/or maneuver the end effector 200 near thetarget tissue more accurately.

The handle 20 comprises a housing 21 configured to house variousmechanical and electrical components and a handle portion 22 extendingfrom the housing 21. The handle portion 22 is configured to fit in thepalm of a user and/or be gripped and/or held by a user using thesurgical stapling instrument 10. The handle 20 further comprises variousactuators and/or triggers configured to be actuated by a user to operateone or more functions of the surgical stapling instrument 10. The handle20 comprises a closure trigger 24, a firing trigger 25, and at least onearticulation actuator 26. When actuated by a user, the closure trigger24 is configured to clamp tissue with the end effector 200 by moving theanvil jaw 203 toward the cartridge jaw 201. When actuated by a user, thefiring trigger 25 is configured to cut and staple tissue with the endeffector 200 by advancing a firing member to eject staples and cuttissue with a knife. When actuated by a user, the articulation actuator26 is configured to articulate the end effector 200 relative to theshaft assembly 100 by way of the articulation region 110. The triggersand actuators of the surgical stapling instrument 10 can either triggerone or more motors within the handle 20 to actuate various function ofthe surgical stapling instrument 10 and/or manually drive various driveshafts and components to actuate various function of the surgicalstapling instrument 10.

The handle 20 further comprises a nozzle assembly 30 configured tosupport the shaft assembly 100 therein. The nozzle assembly 30 comprisesan actuation wheel 31 configured to be rotated by a user to rotate theshaft assembly 100 and end effector 200 about a longitudinal axis LArelative to the handle 20. Such a mechanism permits the user of thesurgical stapling instrument 10 to rotate only the shaft assembly 100and/or end effector 200 without having to rotate the entire handle 20.

The handle 20 further comprises a battery 23 configured to provide powerto various electronic components, sensors, and/or motors of the surgicalstapling instrument 10. Embodiments are envisioned where the surgicalstapling instrument 10 is directly connected to a power source.Embodiments are also envisioned where the surgical stapling instrument10 is entirely manual or, non-powered, for example. Embodiments arefurther envisioned where articulation of the end effector, clamping andunclamping of the jaws, firing of the end effector staple and cuttissue, and shaft and/or end effector rotation are all powered systems.

In at least one instance, the shaft assembly 100 and the end effector200 may be modular and removable from the handle 20. In at least oneinstance, the end effector 200 may be modular in that the end effector200 can be removed from the shaft assembly 100 and replaced with adifferent end effector. In at least one instance, the shaft assembly 100and/or the end effector 200 is employable in a surgical roboticenvironment. Such an embodiment would provide powered inputs from asurgical robotic interface to actuate each function of the end effector200. Examples of such surgical robots and surgical tools are furtherdescribed in U.S. Patent Application Publication No. 2020/0138534,titled ROBOTIC SURGICAL SYSTEM, which published on May 7, 2020, which isincorporated by reference herein in its entirety.

In at least one instance, the shaft assembly 100 and the end effector200 are configured to be used with a surgical robot. In such aninstance, the shaft assembly 100 and the end effector 200 are configuredto be coupled to a surgical robot comprising a plurality of outputdrives. The plurality of output drives of the surgical robot areconfigured to mate with the drive systems of the shaft assembly 100 andend effector 200. In such an instance, the surgical robot can actuatethe various different functions of the end effector 200 such as, forexample, articulating the end effector about multiple differentarticulation joints, rotating the shaft assembly 100 and/or end effector200 about its longitudinal axis, clamping the end effector 200 to clamptissue between the jaws of the end effector 200, and/or firing the endeffector 200 to cut and/or staple tissue.

The shaft assembly 100 is configured to house various drive systemcomponents and/or electronic components of the surgical staplinginstrument 10 so that the end effector 200 and shaft assembly 100 may beinserted through a trocar for laparoscopic surgery. The various drivesystem components are configured to be actuated by the various triggersand actuators of the handle 20. Such components can include drive shaftsfor articulation, drive shafts for clamping and unclamping the endeffector 200, and/or drive shafts for firing the end effector 200. Suchdrive shafts may be rotated by a drive system in the handle 20 or asurgical robotic interface in the instance where the shaft assembly 100is connected to the same. In various aspects, a stapling end effectorcan include two independently rotatable drive members—one for graspingtissue and one for firing staples, for example. The stapling endeffector can further include an articulation joint, and the rotarymotions can be transmitted through the articulation joint. In variousaspects, the stapling end effector can include one or more 3D printedassemblies, which can be incorporated into an articulation, grasping, orfiring systems.

Such drive shafts may be actuated by a drive system in the handle 20 ora surgical robotic interface in the instance where the shaft assembly100 is connected to the same. Such drive shafts may comprise linearactuation, rotary actuation, or a combination thereof. A combination ofrotary actuation and linear actuation may employ a series of rack gearsand/or drive screws, for example.

In at least one instance, the shaft assembly 100 is also configured tohouse electrical leads for various sensors and/or motors, for example,positioned within the shaft assembly 100 and/or end effector 200, forexample.

The shaft assembly 100 comprises an outer shaft 101 extending from thenozzle assembly 30 to the articulation region 110 comprising dualarticulation joints, discussed in greater detail below. The articulationregion 110 allows the end effector 200 to be articulated relative to theouter shaft 101 in two distinct planes about two separate axes AA1, AA2.

Referring now primarily to FIG. 4, articulation of the end effector 200will now be described. The articulation region 110 comprises twodistinct articulation joints and two articulation actuators 150, 160.This allows the end effector 200 to be articulated in two differentplanes about two different axes AA1, AA2 independently of each other.The articulation region 110 comprises a proximal joint shaft component120, an intermediate joint shaft component 130, and a distal joint shaftcomponent 140. The proximal joint shaft component 120 is attached to adistal end of the shaft assembly 100, the intermediate joint shaftcomponent 130 is pivotally connected to the proximal joint shaftcomponent 120 and the distal joint shaft component 140, and the distaljoint shaft component 140 is fixedly attached to the end effector 200 byway of a retention ring 146. Discussed in greater detail below, thisarrangement provides articulation of the end effector 200 relative tothe shaft assembly 100 about axis AA1 and axis AA2 independently of eachother.

The proximal joint shaft component 120 comprises a proximal annularportion 121 fixedly fitted within the outer shaft 101. The proximaljoint shaft component 120 also includes a hollow passage 122 to allowvarious drive system components to pass therethrough, and furtherincludes an articulation tab 123 comprising a pin hole 124 configured toreceive articulation pin 125. The articulation pin 125 pivotallyconnects the proximal joint shaft component 120 to a proximalarticulation tab 131 of the intermediate joint shaft component 130. Toarticulate the end effector 200 about axis AA1, the articulationactuator 150 is actuated linearly either in a distal direction or aproximal direction. Such an actuator may comprise a bar or rod made ofany suitable material such as metal and/or plastic, for example. Thearticulation actuator 150 is pivotally mounted to an articulationcrosslink 151. The articulation crosslink 151 is pivotally mounted tothe intermediate joint shaft component 130 off-axis relative to thearticulation pin 125 so that when the articulation actuator 150 isactuated, a torque is applied to the intermediate joint shaft component130 off-axis relative to the articulation pin 125 by the articulationcrosslink 151 to cause the intermediate joint shaft component 130 and,thus, the end effector 200, to pivot about axis AA1 relative to theproximal joint shaft component 120.

The intermediate joint shaft component 130 is pivotally connected to theproximal joint shaft component 120 by way of the articulation pin 125which defines axis AA1. Specifically, the intermediate joint shaftcomponent 130 comprises a proximal articulation tab 131 that ispivotally connected to the proximal joint shaft component 120 by way ofthe articulation pin 125. The intermediate joint shaft component 130further comprises a hollow passage 132 configured to allow various drivesystem components to pass therethrough and a distal articulation tab133. The distal articulation tab 133 comprises a pin hole 134 configuredto receive another articulation pin 136, which defines axis AA2, and adistally-protruding key 135.

To articulate the end effector 200 about axis AA2, the articulationcable 160 is actuated to apply an articulation torque to a proximal tab141 of the distal joint shaft component 140 by way of the key 135. Thearticulation cable 160 is fixed to the key 135 such that, as the cable160 is rotated, the key 135 is pivoted relative to the intermediatejoint shaft component 130. The key 135 is fitted within a key hole 144of the distal joint shaft component 140. Notably, the key 135 is notfixed to the intermediate joint shaft component 130 and the key 135 canbe rotated relative to the intermediate joint shaft component 130. Thearticulation cable 160 also contacts the proximal tab 141 around the pinhole 142. This provides an additional torque moment from thearticulation cable 160 to the distal joint shaft component 140. Thearticulation pin 136 is received within the pin hole 142 to pivotallycouple the intermediate joint shaft component 130 and the distal jointshaft component 140.

In at least one instance, the articulation cable 160 is only able to bepulled in a proximal direction. In such an instance, only one side ofthe articulation cable 160 would be pulled proximally to articulate theend effector 200 in the desired direction. In at least one instance, thearticulation cable 160 is pushed and pulled antagonistically. In otherwords, the cable 160 can comprise a rigid construction such that oneside of the articulation cable 160 is pushed distally while the otherside of the articulation cable 160 is pulled proximally. Such anarrangement can allow the articulation forces to be divided between thepushed half of the cable 160 and the pulled half of the cable 160. In atleast one instance, the push-pull arrangement allows greaterarticulation forces to be transmitted to the corresponding articulationjoint. Such forces may be necessary in an arrangement with twoarticulation joints. For example, if the proximal articulation joint isfully articulated, more force may be required of the articulationactuator meant to articulate the distal articulation joint owing to thestretching and/or lengthened distance that the articulation actuator forthe distal articulation joint must travel.

The distal joint shaft component 140 further comprises a cutout 143 toallow various drive components to pass therethrough. The retention ring146 secures a channel 210 of the cartridge jaw 201 to the distal jointshaft component 140 thereby fixing the end effector assembly 200 to adistal end of the articulation region 110.

As discussed above, the anvil jaw 201 is movable relative to thecartridge jaw 203 to clamp and unclamp tissue with the end effector 200.Operation of this function of the end effector 200 will now bedescribed. The cartridge jaw 201 comprises the channel 210 and a staplecartridge 220 configured to be received within a cavity 214 of thechannel 210. The channel 210 further comprises an annular groove 211configured to receive the retention ring 146 and a pair of pivot holes213 configured to receive a jaw-coupling pin 233. The jaw coupling pin233 permits the anvil jaw 203 to be pivoted relative to the cartridgejaw 201.

The anvil jaw 203 comprises an anvil body 230 and a pair of pivot holes231. The pivot holes 231 in the proximal portion of the anvil jaw 203are configured to receive the jaw-coupling pin 233 thereby pivotallycoupling the anvil jaw 203 to the cartridge jaw 201. To open and closethe anvil jaw 203 relative to the cartridge jaw 201, a closure drive 250is provided.

The closure drive 250 is actuated by a flexible drive segment 175comprised of universally-movable joints arranged or formed end-to-end.In various instances, the flexible drive segment 175 can includes serial3D-printed universal joints, which are printed all together as a singlecontinuous system. Discussed in greater detail below, the flexible drivesegment 175 is driven by an input shaft traversing through the shaftassembly 100. The flexible drive segment 175 transmits rotary actuationmotions through the dual articulation joints. The closure drive 250comprises a closure screw 251 and a closure wedge 255 threadably coupledto the closure screw 251. The closure wedge 255 is configured topositively cam the anvil jaw 203 open and closed. The closure screw 251is supported by a first support body 258 and a second support body 259secured within the channel 210.

To move the anvil jaw 203 between a clamped position (FIG. 8) and anunclamped position (FIG. 7), a closure drive shaft is actuated toactuate the flexible drive segment 175. The flexible drive segment 175is configured to rotate the closure screw 251, which displaces theclosure wedge 255. For example, the closure wedge 255 is threadablycoupled to the closure screw 251 and rotational travel of the closurewedge 255 with the staple cartridge 220 is restrained. The closure screw251 drives the closure wedge 255 proximally or distally depending onwhich direction the closure screw 251 is rotated.

To clamp the end effector 200 from an unclamped position (FIG. 7), theclosure wedge 255 is moved proximally. As the closure wedge 255 is movedproximally, a proximal cam surface 256 of the closure wedge 255 contactsa corresponding cam surface 234 defined in a proximal end 235 of theanvil body 230. As the cam surface 256 contacts the cam surface 234, aforce is applied to the proximal end 235 of the anvil body 230 causingthe anvil body 230 to rotate into the clamped position (FIG. 8) aboutthe pin 233.

To open or unclamp the end effector 200 from a clamped position (FIG.8), the closure wedge 255 is moved distally by rotating the closurescrew 251 in a direction opposite to the direction that causes theclosure wedge 255 to move proximally. As the closure wedge 255 is moveddistally, a pair of nubs 257 extending from a distal end of the closurewedge 255 contact the cam surface 234 near a downwardly extending tab237 of the anvil body 230. As the nubs 257 contact the cam surface 234near the tab 237, a force is applied to the anvil body 230 to rotate theanvil body 230 into the open position (FIG. 7) about the pin 233.

In at least one instance, the profile of the cam surface 234 correspondsto the profile of the cam surface 256. For example, the cam surface 234and the cam surface 256 may match such that a maximum cam force isapplied to the anvil body 230 to cause the desired rotation of the anvilbody 230. As can be seen in FIG. 8, for example, the cam surface 234defined by the proximal end 235 of the anvil body 230 comprises a rampedsection similar to that of the upper ramped section of the cam surface256.

As discussed above, the surgical stapling instrument 10 may be actuatedto advance a firing member through the jaws 201, 203 to staple and cuttissue with the end effector 200. The function of deploying staples 226from the staple cartridge 220 and cutting tissue with knife 283 will nowbe described. The staple cartridge 220 comprises a cartridge body 221, aplurality of staple drivers 225, and a plurality of staples 226removably stored within the cartridge body 221. The cartridge body 221comprises a deck surface 222, a plurality of staple cavities 223arranged in longitudinal rows defined in the cartridge body 221, and alongitudinal slot 224 bifurcating the cartridge body 221. The knife 283is configured to be driven through the longitudinal slot 224 to cuttissue clamped between the anvil body 230 and the deck surface 221.

The deck surface 221 comprises a laterally-contoured tissue-supportingsurface. In various aspects, the contour of the deck surface 221 canform a peak along a central portion of the cartridge body 221. Such apeak can overlay a longitudinally-extending firing screw 261 thatextends through the central portion of the cartridge body 221, which isfurther described herein. The increased height along the peak can beassociated with a smaller tissue gap along a firing path of the knife283 in various instances. In certain aspects of the present disclosure,driver heights, formed staple heights, staple pocket extension heights,and/or staple overdrive distances can also vary laterally along the decksurface 221. Laterally-variable staple formation (e.g. a combination of2D staples and 3D staples) is also contemplated and further describedherein.

The staple drivers 225 are configured to be lifted by a sled 280 as thesled 280 is pushed distally through the staple cartridge 220 to ejectthe staples 226 supported by the staple drivers 225 in the staplecavities 223. The sled 280 comprises ramps 281 to contact the stapledrivers 225. The sled 280 also includes the knife 283. The sled 280 isconfigured to be pushed by a firing member 270.

To deploy the staples 226 and cut tissue with the knife 283, the endeffector 200 comprises a firing drive 260. The firing drive 260 isactuated by a flexible drive shaft 176. Discussed in greater detailbelow, the flexible drive shaft 176 is driven by an input shafttraversing through the shaft assembly 100. The flexible drive shaft 176transmits rotary actuation motions through the dual articulation joints.The firing drive 260 comprises a firing screw 261 configured to berotated by the flexible drive shaft 176. The firing screw 261 comprisesjournals supported within bearings in the support member 259 and thechannel 210. In various instances, the firing screw 261 can floatrelative to the channel 210, as further described herein. The firingscrew 261 comprises a proximal end 262 supported within the supportmember 259 and the channel 210, a distal end 263 supported within thechannel 210, and threads 265 extending along a portion of the length ofthe firing screw 261.

The firing member 270 is threadably coupled to the firing screw 261 suchthat as the firing screw 261 is rotated, the firing member 270 isadvanced distally or retracted proximally along the firing screw 261.Specifically, the firing member 270 comprises a body portion 271comprising a hollow passage 272 defined therein. The firing screw 261 isconfigured to be received within the hollow passage 272 and isconfigured to be threadably coupled with a threaded component 273 of thefiring member 270. Thus, as the firing screw 261 is rotated, thethreaded component 273 applies a linear force to the body portion 271 toadvance the firing member 270 distally or retract the firing member 270proximally. As the firing member 270 is advanced distally, the firingmember 270 pushes the sled 280. Distal movement of the sled 280 causesthe ejection of the staples 223 by engaging the plurality of stapledrivers 225, as further described herein. The driver 225 is a tripledriver, which is configured to simultaneously fire multiple staples 223.The driver 225 can comprise lateral asymmetries, as further describedherein, to maximum the width of the sled rails and accommodate thefiring screw 261 down the center of the cartridge 220 in variousinstances.

At a point during firing of the end effector 200, a user may retract thefiring member 270 to allow unclamping of the jaws 201, 203. In at leastone instance, the full retraction of the firing member 270 is requiredto open the jaws 201, 203 where upper and lower camming members areprovided on the body portion 271 which can only be disengaged from thejaws 201, 203 once the firing member 270 is fully retracted.

In various instances, the firing member 270 can be a hybrid constructionof plastic and metal portions as further described herein. In variousinstances, the threaded component 273 can be a metal component, forexample, which is incorporated into the firing member body 271 withinsert molding or over molding.

The firing member 270 can also be referred to an I-beam in certaininstances. The firing member 270 can include a complex 3D-printedgeometry comprising a lattice pattern of spaces therein. In variousinstances, 3D printing can allow the firing member or a portion thereofto act as a spring and allows a portion to more readily flex, which canimprove the force distribution and/or tolerances during a firing stroke,for example.

FIGS. 9-11 depict a surgical stapling assembly 300 comprising a shaftassembly 310 and the end effector 200 of FIGS. 1-8 attached to the shaftassembly 310. The shaft assembly 310 may be similar in many respects tovarious other shaft assemblies discussed herein; however, the shaftassembly 310 comprises a single articulation joint and an articulationbar configured to articulate the end effector 200 about the singlearticulation joint. The surgical stapling assembly 300 is configured tocut and staple tissue. The surgical stapling assembly 300 may beattached to a surgical instrument handle and/or surgical roboticinterface. The surgical instrument handle and/or surgical roboticinterface can be configured to actuate various functions of the surgicalstapling assembly 300. The shaft assembly 310 comprises an articulationjoint 320. Discussed in greater detail below, the end effector 200 isconfigured to be articulated relative to an outer shaft 311 of the shaftassembly 310 about axis AA.

The shaft assembly 310 comprises the outer shaft 311, a first shaftjoint component 330, and a second shaft joint component 350 pivotallycoupled to the first shaft joint component 330 by way of an articulationpin 354. The first shaft joint component 330 comprises a proximal tubeportion 331 configured to fit within the inner diameter of the outershaft 311. Such a fit may comprise a press fit, for example. However,any suitable attachment means can be used. The first shaft jointcomponent 330 also includes a distal portion 332. The distal portion 332comprises an articulation tab 333 comprising a pin hole 334 definedtherein and a hollow passage 335 through which various drive componentsof the surgical stapling assembly 300 can pass. Such drive componentscan include articulation actuators, closure actuators, and/or firingactuators for example.

The first shaft joint component 330 is pivotally connected to the secondshaft joint component 350 by way of the articulation pin 354. Thearticulation pin 354 is also received within a pin hole 353 of aproximally-extending articulation tab 351 of the second shaft jointcomponent 350. The pin hole 353 is axially aligned with the pin hole334. The articulation pin 354 allows the second shaft joint component350 to be articulated relative to the first shaft joint component 330about the articulation axis AA. The second shaft joint component 350further comprises a pin protrusion 352 extending from theproximal-extending articulation tab 351. Discussed in greater detailbelow, the pin protrusion 352 is configured to be pivotally coupled toan articulation drive system. The second shaft joint component 350further comprises a distal portion 355 comprising an annular groove 356configured to receive a retention ring 358. The distal portion 355 alsoincludes a hollow passage 357 through which various drive components ofthe surgical stapling assembly 300 can pass. The retention ring 358 isconfigured to hold the first jaw 201 to the second shaft joint component350 by fitting within the annular groove 211 of the cartridge channel210 and the annular groove 356 of the second shaft joint component 350.

To articulate the end effector 200 about the articulation axis AA, anarticulation bar 360 is provided. The articulation bar 360 may beactuated by any suitable means such as, for example, by a robotic ormotorized input and/or a manual handle trigger. The articulation bar 360may be actuated in a proximal direction and a distal direction, forexample. Embodiments are envisioned where the articulation systemcomprises rotary driven actuation in addition to or, in lieu of, linearactuation. The articulation bar 360 extends through the outer shaft 311.The articulation bar 360 comprises a distal end 361 pivotally coupled toan articulation link 362. The articulation link 362 is pivotally coupledto the pin protrusion 352 extending from the proximally-extendingarticulation tab 351 off center with respect to the articulation axisAA. Such off-center coupling of the articulation link 362 allows thearticulation bar 360 to apply a force to the second joint shaftcomponent 350 to rotate the second shaft joint component 350 and, thus,the end effector 200, relative to the first joint shaft component 330.The articulation bar 360 can be advanced distally to rotate the endeffector 200 in a first direction about the articulation axis AA andretracted proximally to rotate the end effector 200 in a seconddirection opposite the first direction about the articulation axis AA.

The shaft assembly 310 further comprises an articulation componentsupport structure 340 positioned within the articulation joint 320. Sucha support structure can provide support to various drive componentsconfigured to pass through the articulation joint 320 to the endeffector 200 as the end effector 200 is articulated. The supportstructure 340 may also serve to isolate the drive components from tissueremnants during use.

FIGS. 12-14 depict a surgical stapling assembly 400 comprising a shaftassembly 410 and the end effector 200 of FIGS. 1-8 attached to the shaftassembly 410. The shaft assembly 410 may be similar in many respects tovarious other shaft assemblies discussed herein; however, the shaftassembly 410 comprises a single articulation joint and an articulationcable configured to articulate the end effector 200 about the singlearticulation joint. The surgical stapling assembly 400 is configured tocut and staple tissue. The surgical stapling assembly 400 may beattached to a surgical instrument handle and/or surgical roboticinterface. The surgical instrument handle and/or surgical roboticinterface can be configured to actuate various functions of the surgicalstapling assembly 400. The shaft assembly 410 comprises an articulationjoint 420. Discussed in greater detail below, the end effector 200 isconfigured to be articulated relative to an outer shaft 411 of the shaftassembly 310 about an axis AA.

The shaft assembly 410 comprises the outer shaft 411, a first shaftjoint component 430, and a second shaft joint component 450 pivotallycoupled to the first shaft joint component 430 by way of an articulationpin 454. The first shaft joint component 430 comprises a proximal tubeportion 431 configured to fit within the inner diameter of the outershaft 411. Such a fit may comprise a press fit, for example. However,any suitable attachment means can be used. The first shaft jointcomponent 430 also includes a distal portion 432, which comprises anarticulation tab 433 comprising a pin hole 434 defined therein. Thedistal portion 432 further defines a hollow passage 435 through whichvarious drive components of the surgical stapling assembly 400 can pass.Such drive components can include articulation actuators, closureactuators, and/or firing actuators, for example.

The first shaft joint component 430 is pivotally connected to the secondshaft joint component 450 by way of the articulation pin 454. Thearticulation pin 454 is also received within a pin hole 453 of aproximally-extending articulation tab 451 of the second shaft jointcomponent 450. The articulation pin 454 allows the second shaft jointcomponent 450 to be articulated relative to the first shaft jointcomponent 430 about the articulation axis AA. The second shaft jointcomponent 450 further comprises a drive ring structure 452. The drivering structure 452 extends from the proximally-extending articulationtab 451 and further defines a portion of the pin hole 453. Discussed ingreater detail below, the drive ring structure 452 is configured to beengaged by an articulation drive system. The second shaft jointcomponent 450 further comprises a distal portion 455 comprising anannular groove 456 configured to receive a retention ring 458. A hollowpassage 457 through the distal portion 455 is configured to receivevarious drive components of the surgical stapling assembly 400therethrough. The retention ring 458 is configured to hold the first jaw201 to the second shaft joint component 450 by fitting within theannular groove 211 of the cartridge channel 210 and the annular groove456 of the second shaft joint component 450.

To articulate the end effector 200 about the articulation axis AA, anarticulation cable 460 is provided. The articulation cable 460 may beactuated by any suitable means such as, for example, by a robotic inputand/or a manual trigger on a handle of a handheld surgical instrument.The articulation cable 460 may comprise an antagonistic actuationprofile. In other words, as a first side of the articulation cable 460is pulled proximally a second side of the articulation cable 460 isallowed to advance distally like a pulley system. Similarly, as thesecond side is pulled proximally, the first side is allowed to advancedistally. The articulation cable 460 extends through the outer shaft411. The articulation cable 460 is positioned around the drive ringstructure 452 and frictionally retained thereon to permit rotation ofthe second shaft joint component 450 as the articulation cable 460 isactuated. As the articulation cable 460 is actuated, the articulationcable 460 is configured to apply a rotational torque to the drive ringstructure 452 of the second joint shaft component 450 and, thus, the endeffector 200. Such torque is configured to cause the second joint shaftcomponent 450 to rotate, or pivot, relative to the first joint shaftcomponent 430 thereby articulating the end effector 200 relative to theouter shaft 411. A first side of the articulation cable 460 can pulledto rotate the end effector 200 in a first direction about thearticulation axis AA and a second side of the articulation cable 460 canbe pulled to rotate the end effector 200 in a second direction oppositethe first direction about the articulation axis AA.

The shaft assembly 410 further comprises an articulation componentsupport structure 440 positioned within the articulation joint 420. Sucha support structure 440 can provide support to various drive componentsconfigured to pass through the articulation joint 420 to the endeffector 200 as the end effector 200 is articulated. The supportstructure 440 may also serve to isolate the drive components from tissueremnants during use.

The surgical stapling assembly 400 further comprises a closure driveshaft segment 475 and a firing drive shaft segment 476 each configuredto transmit rotary motion through the articulation joint 420 to the endeffector 200. The drive shaft segments 475, 476 are configured topassively expand and contract longitudinally as the end effector 200 isarticulated. For example, articulation can cause expansion andcontraction of the drive shaft segments 475, 476 to account for therespective longitudinal stretching of or contracting of the length ofthe drive shafts owing to articulation of the end effector 200 relativeto the shaft assembly 410. During expansion and contraction of the driveshaft segments 475, 476, the drive shaft segments 475, 476 maintainrotary driving engagement with corresponding input shafts extendingthrough the outer shaft 411 and output shafts in the end effector 200.In at least one instance, the output shafts comprise the closure screw251, which is configured to effect grasping, closing, or tissuemanipulation with the jaws 201, 203, and the firing screw 261, which isconfigured to effect clamping of the jaws 201, 203 and firing of thefiring member 270.

FIGS. 15-17 depict a surgical stapling assembly 500 comprising a shaftassembly 510 and the end effector 200 of FIGS. 1-8 attached to the shaftassembly 510. The shaft assembly 510 may be similar in many respects tovarious other shaft assemblies discussed herein; however, the shaftassembly 510 comprises a single articulation joint and drive shaftsegments configured to passively expand and contract. The surgicalstapling assembly 500 is configured to cut and staple tissue. Thesurgical stapling assembly 500 may be attached to a surgical instrumenthandle and/or surgical robotic interface. The surgical instrument handleand/or surgical robotic interface can be configured to actuate variousfunctions of the surgical stapling assembly 500. The shaft assembly 510comprises an articulation joint 520. Discussed in greater detail below,the end effector 200 is configured to be articulated about an axis AA.

The shaft assembly 510 comprises a first shaft joint component 530 and asecond shaft joint component 540 pivotally coupled to the first shaftjoint component 530 by way of an articulation pin 543. The first shaftjoint component 530 is configured to be attached to a shaft of asurgical instrument assembly and/or a surgical robotic interface. Thefirst shaft joint component 530 comprises a proximal portion 531 and anarticulation tab 533 comprising a pin hole 534 defined therein. In atleast one instance, the first shaft joint component 530 comprises ahollow passage through which various drive components of the surgicalstapling assembly 400 can pass. Such drive components can includearticulation actuators, closure actuators, and/or firing actuators forexample.

The first shaft joint component 530 is pivotally connected to the secondshaft joint component 540 by way of the articulation pin 543. Thearticulation pin 543 is also received within a pin hole 542 of aproximally-extending articulation tab 541 of the second shaft jointcomponent 540. The articulation pin 543 allows the second shaft jointcomponent 540 to be articulated relative to the first shaft jointcomponent 530 about the articulation axis AA. The second shaft jointcomponent 540 further comprises a distal portion 545 comprising anannular groove 547 configured to receive a retention ring 548 and ahollow passage 546 through which various drive components of thesurgical stapling assembly 500 can pass. The retention ring 548 isconfigured to hold the first jaw 201 to the second shaft joint component540 by fitting within the annular groove 211 of the cartridge channel210 and the annular groove 547 of the second shaft joint component 540.

Any suitable articulation drive system can be used to articulate the endeffector 200 about axis AA. In at least one instance, the end effector200 is passively articulated. In such an instance, the end effector 200may be pressed against tissue, for example, to apply a force to the endeffector 200 and cause the end effector 200 to articulate about anarticulation axis. In at least one instance, the end effector 200further comprises a spring configured to apply a neutral biasing forceto the second shaft joint segment 540, for example, to cause the endeffector 200 to be biased toward an unarticulated configuration.

The surgical stapling assembly 500 further comprises a closure driveshaft segment 575 and a firing drive shaft segment 576 each configuredto transmit rotary motion through the articulation joint 520 to the endeffector 200. The drive shaft segments 575, 576 are configured topassively expand and contract longitudinally as the end effector 200 isarticulated. Articulation causes the drive shaft segments 575, 576 toexpand and contract to account for the longitudinal stretching of orcontracting of the length of the drive shafts owing to articulation ofthe end effector 200. During expansion and contraction of the driveshaft segments 575, 576, the drive shaft segments 575, 576 maintainrotary driving engagement with corresponding input shafts and outputshafts in the end effector 200. In at least one instance, the outputshafts comprise the closure screw 251 and the firing screw 261, whichare further described herein.

FIGS. 18-20 depict a surgical stapling end effector assembly 600comprising a shaft portion 610 and an end effector 600. The end effectorassembly 600 is similar in many respects to various other end effectorassemblies disclosed herein; however, the end effector assembly 600comprises a multi-component firing member driven by a flexible firingshaft. The end effector assembly 600 is configured to cut and stapletissue. The end effector assembly 600 may be attached to a surgicalinstrument handle and/or surgical robotic interface by way of a proximaltab 611 of the shaft portion 610. The surgical instrument handle and/orsurgical robotic interface can be configured to actuate variousfunctions of the end effector assembly 600. The end effector assembly600 comprises a cartridge channel jaw 620 and an anvil jaw 660 pivotallymounted to the cartridge channel jaw 620 to clamp tissue between thecartridge channel jaw 620 and the anvil jaw 660.

The cartridge channel jaw 620 comprises a channel 630 comprising aproximal end 631, a staple cartridge 640 configured to store a pluralityof staples therein and configured to be received within the channel 630,and a support brace 650 fitted within the staple cartridge 640. Thestaple cartridge 640 and the support brace 650 are configured to beassembled together prior to installing the staple cartridge 640 into thechannel 630. Discussed in greater detail below, the support brace 650 isconfigured to further support a firing member assembly as the firingmember assembly is advanced through the end effector assembly 600.

The anvil jaw 660 is configured to form staples ejected from the staplecartridge 640. The anvil jaw 660 comprises a proximal end 661 comprisinga pair of pin holes 662 defined therein configured to receive a couplingpin 663. The anvil jaw 660 is pivotable about the coupling pin 663between an unclamped position and a fully clamped position. The couplingpin 663 is also received within a pair of pin holes 633 defined in theproximal end 631 of the channel 630. The coupling pin 663 serves topivotally mount the anvil jaw 660 to the channel 630. In at least oneinstance, the channel 630 is mounted to the shaft portion 610 by way ofa retention ring, or band, that fits around an annular groove 632 of thechannel 630 and annular groove 615 of the shaft portion 610. Theretention ring, or band, is configured to hold the channel 630 to theshaft portion 610.

The end effector assembly 600 comprises a closure drive 670 configuredto grasp tissue between the anvil jaw 660 and the cartridge channel jaw620 by pivoting the anvil jaw 660 relative to the channel 630. The endeffector assembly 600 also includes a firing drive 680 configured toclamp, staple, and cut tissue by deploying a plurality of staples fromthe staple cartridge 640. The closure drive 670 comprises a closurescrew 671 positioned within the channel 630 and a closure wedge 675threadably coupled to the closure screw 671. As the closure screw 671 isrotated, the closure wedge 675 is advanced distally or retractedproximally to open or close the anvil jaw 660, respectively. The closuredrive 670 may be actuated by any suitable means. For example, a rotarydrive shaft may extend through the shaft portion 610 from an actuationinterface, for example, to rotate the closure screw 671. Other examplesof suitable rotary drive shafts are further described herein.

The firing drive 680 comprises a flexible drive shaft 681 that isconfigured to be moved linearly through the end effector assembly 600.The flexible drive shaft 681 may be actuated by a robotic input and/or amanually-actuated drive shaft of a handle assembly, for example. Theflexible drive shaft 681 is configured to extend through a hollowpassage 614 of a distal end 613 of the shaft portion 610 and is flexibleso that the end effector assembly 600 may be articulated relative to ashaft from which the end effector 600 extends. The flexible drive shaft681 extends through a clearance slot 676 defined in the closure wedge675 and is fixedly attached to a lower firing member 682. The lowerfiring member 682 is configured to be reused with different staplecartridges.

The staple cartridge 640 comprises a disposable upper firing member 683configured to hookingly engage or, latch, onto the lower firing member682 such that the lower firing member 582 can push or, drive, the upperfiring member 683 through the staple cartridge 640 and support brace650. In other words, the firing actuation involves a two-part firingmember—a disposable upper firing member 683 incorporated into thecartridge 640 and a reusable lower firing member 682 incorporated intothe firing drive 680, which can be coupled together when the cartridge640 is seated in the elongate channel 630. The two-part firing member isfurther described herein.

The upper firing member 683 comprises an upper flange configured toengage and position the anvil jaw 660, a knife edge configured to cuttissue, and a latch portion configured to hookingly engage the lowerfiring member 682. The staple cartridge 640 further comprises a sled 684configured to engage staple drivers positioned within the staplecartridge 640 to eject staples from the staple cartridge 640. Because aknife and cutting edge are incorporated into the disposable upper firingmember 683 of the staple cartridge 640, a new and/or fresh cutting edgecan be supplied with each staple cartridge loaded into the end effectorassembly 600.

The lower firing member 682 and the upper firing member 683 areconfigured to move through the support brace 650 such that the verticalloads associated with the firing sequence are configured to bedistributed through the support brace 650, the staple cartridge 640, thechannel 630, and the anvil jaw 660. The support brace 650 may becomprised of a metal material, for example, to be inserted within thestaple cartridge 640. The support brace 650 comprises key rails 655configured to fit within corresponding key slots defined in alongitudinal slot of the staple cartridge 640. The support brace 650further comprises a longitudinal slot 653 configured to receive theknife of the upper firing member 683, a cylindrical passage 657configured to receive a portion of the upper firing member 683, aportion of the lower firing member 682, and the flexible drive shaft681. The support brace 650 further comprises vertical key extensions 656configured to be received within corresponding key holes in thecartridge deck. Such extensions may be visible through the cartridgedeck when the support brace 650 is installed within the staple cartridge640. In at least one instance, the support brace 650 is configured to beinserted into the staple cartridge 640 from the bottom of the staplecartridge 640 facing the channel 630.

The support brace 650 further comprises a proximal tab 651 and a distaltab 653, which are both configured to be engaged with the channel 630.The tabs 651, 653 are configured to distribute at least some of theforces transmitted through the assembly 600 by the firing drive 680 andcorresponding components. The distal tab 651 may serve to block theupper and lower firing members 683, 682 from being pushed through adistal end of the support brace 650 by sharing and/or redistributing theload applied to the support brace 650 by the firing drive 680 with thechannel 630.

When the staple cartridge 640 is replaced so that the end effectorassembly 600 can be reused, the staple cartridge 640 is removed from thechannel jaw 630. Removing the staple cartridge 640 from the channel jaw630 removes the upper firing member 683, the sled 684, the support brace650, and the staple cartridge 640. A fresh knife can be provided with areplacement staple cartridge.

Various embodiments disclosed herein may be employed in connection witha robotic system 700. An exemplary robotic system is depicted in FIGS.21-23, for example. FIG. 21 depicts a master controller 701 that may beused in connection with a surgical robot, such as the robotic arm slavecart 800 depicted in FIG. 22, for example. Master controller 701 androbotic arm slave cart 800, as well as their respective components andcontrol systems are collectively referred to herein as a robotic system700. Examples of such systems and devices are disclosed in U.S. Pat. No.7,524,320, entitled MECHANICAL ACTUATOR INTERFACE SYSTEM FOR ROBOTICSURGICAL TOOLS, as well as U.S. Pat. No. 9,072,535, entitled SURGICALSTAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS,which are each hereby incorporated by reference herein in theirrespective entireties. As is known, the master controller 701 generallyincludes controllers (generally represented as 703 in FIG. 21) which aregrasped by the surgeon and manipulated in space while the surgeon viewsthe procedure via a stereo display 702. The controllers 701 generallycomprise manual input devices which preferably move with multipledegrees of freedom, and which often further have an actuatable handle,trigger, or actuator for actuating tools (for example, for closinggrasping jaws, applying an electrical potential to an electrode, or thelike).

As can be seen in FIG. 22, in one form, the robotic arm cart 800 may beconfigured to actuate one or more surgical tools, generally designatedas 900. Various robotic surgery systems and methods employing mastercontroller and robotic arm cart arrangements are disclosed in U.S. Pat.No. 6,132,368, entitled MULTI-COMPONENT TELEPRESENCE SYSTEM AND METHOD,the entire disclosure of which is hereby incorporated by referenceherein.

In various forms, the robotic arm cart 800 includes a base 702 fromwhich, in the illustrated embodiment, surgical tools 900 may besupported. In various forms, the surgical tool(s) 900 may be supportedby a series of manually articulatable linkages, generally referred to asset-up joints 804, and a robotic manipulator 806. In variousembodiments, the linkage and joint arrangement may facilitate rotationof a surgical tool around a point in space, as more fully described inU.S. Pat. No. 5,817,084, entitled REMOTE CENTER POSITIONING DEVICE WITHFLEXIBLE DRIVE, the entire disclosure of which is hereby incorporated byreference herein. The parallelogram arrangement constrains rotation topivoting about an axis 812 a, sometimes called the pitch axis. The linkssupporting the parallelogram linkage are pivotally mounted to set-upjoints 804 (FIG. 22) so that the surgical tool further rotates about anaxis 812 b, sometimes called the yaw axis. The pitch and yaw axes 812 a,812 b intersect at the remote center 814, which is aligned along anelongate shaft of the surgical tool 900. The surgical tool 900 may havefurther degrees of driven freedom as supported by the manipulator 806,including sliding motion of the surgical tool 900 along the longitudinalaxis “LT-LT”. As the surgical tool 900 slides along the tool axis LT-LTrelative to manipulator 806 (arrow 812 c), the remote center 814 remainsfixed relative to the base 816 of the manipulator 806. Hence, the entiremanipulator is generally moved to re-position the remote center 814.Linkage 808 of manipulator 806 may be driven by a series of motors 820.These motors actively move linkage 808 in response to commands from aprocessor of a control system. The motors 820 may also be employed tomanipulate the surgical tool 900. Alternative joint structures and setup arrangements are also contemplated. Examples of other joint and setup arrangements, for example, are disclosed in U.S. Pat. No. 5,878,193,entitled AUTOMATED ENDOSCOPE SYSTEM FOR OPTIMAL POSITIONING, the entiredisclosure of which is hereby incorporated by reference herein.

While the data communication between a robotic component and theprocessor of the robotic surgical system is primarily described hereinwith reference to communication between the surgical tool and the mastercontroller 701, it should be understood that similar communication maytake place between circuitry of a manipulator, a set-up joint, anendoscope or other image capture device, or the like, and the processorof the robotic surgical system for component compatibility verification,component-type identification, component calibration (such as off-set orthe like) communication, confirmation of coupling of the component tothe robotic surgical system, or the like. In accordance with at leastone aspect, various surgical instruments disclosed herein may be used inconnection with other robotically-controlled or automated surgicalsystems and are not necessarily limited to use with the specific roboticsystem components shown in FIGS. 21-23 and described in theaforementioned references.

It is common practice during various laparoscopic surgical procedures toinsert a surgical end effector portion of a surgical instrument througha trocar that has been installed in the abdominal wall of a patient toaccess a surgical site located inside the patient's abdomen. In itssimplest form, a trocar is a pen-shaped instrument with a sharptriangular point at one end that is typically used inside a hollow tube,known as a cannula or sleeve, to create an opening into the body throughwhich surgical end effectors may be introduced. Such arrangement formsan access port into the body cavity through which surgical end effectorsmay be inserted. The inner diameter of the trocar's cannula necessarilylimits the size of the end effector and drive-supporting shaft of thesurgical instrument that may be inserted through the trocar.

Regardless of the specific type of surgical procedure being performed,once the surgical end effector has been inserted into the patientthrough the trocar cannula, it is often necessary to move the surgicalend effector relative to the shaft assembly that is positioned withinthe trocar cannula in order to properly position the surgical endeffector relative to the tissue or organ to be treated. This movement orpositioning of the surgical end effector relative to the portion of theshaft that remains within the trocar cannula is often referred to as“articulation” of the surgical end effector. A variety of articulationjoints have been developed to attach a surgical end effector to anassociated shaft in order to facilitate such articulation of thesurgical end effector. As one might expect, in many surgical procedures,it is desirable to employ a surgical end effector that has as large arange of articulation as possible.

Due to the size constraints imposed by the size of the trocar cannula,the articulation joint components must be sized so as to be freelyinsertable through the trocar cannula. These size constraints also limitthe size and composition of various drive members and components thatoperably interface with the motors and/or other control systems that aresupported in a housing that may be handheld or comprise a portion of alarger automated system. In many instances, these drive members mustoperably pass through the articulation joint to be operably coupled toor operably interface with the surgical end effector. For example, onesuch drive member is commonly employed to apply articulation controlmotions to the surgical end effector. During use, the articulation drivemember may be unactuated to position the surgical end effector in anunarticulated position to facilitate insertion of the surgical endeffector through the trocar and then be actuated to articulate thesurgical end effector to a desired position once the surgical endeffector has entered the patient.

Thus, the aforementioned size constraints form many challenges todeveloping an articulation system that can effectuate a desired range ofarticulation, yet accommodate a variety of different drive systems thatare necessary to operate various features of the surgical end effector.Further, once the surgical end effector has been positioned in a desiredarticulated position, the articulation system and articulation jointmust be able to retain the surgical end effector in that locked positionduring the actuation of the end effector and completion of the surgicalprocedure. Such articulation joint arrangements must also be able towithstand external forces that are experienced by the end effectorduring use.

Various surgical instruments employ a variety of different drive shaftarrangements that serve to transmit drive motions from a correspondingsource of drive motions that is supported in a handle of the surgicalinstrument or other portion of an automated or robotically controlledsystem. These drive shaft arrangements must be able to accommodatesignificant articulated orientations of the end effector whileeffectively transmitting such drive motions across the articulationjoint of the surgical instrument. In addition, due to theabove-mentioned size constraints dictated by the sizes of trocarsthrough which the instrument shafts must be inserted, these drive shaftcomponents must occupy as little space as possible within the shaft. Toaccommodate such requirements, many drive shaft arrangements compriseseveral movable elements that are coupled together in series. The smallsizes (e.g., 4 mm diameter) and numbers of components lead to difficultand lengthy assembly procedures that add to the cost and complexity ofthe device.

As further described herein, a powered stapling device can include twoindependently rotatable drive members: a first rotary drive memberconfigured to effect closing of the jaws of the end effector and asecond rotary drive member configured to effect firing of a staplecartridge installed in the end effector. The first and second rotarydrive members are flexible and configured to extend through at least onearticulation joint. In such instances, the first and second rotary drivemembers can transmit rotary actuation motions through the articulationjoint(s) when in a non-flexed configuration and when in a flexedconfiguration. Exemplary rotary drive members are further describedherein.

The powered stapling assembly further comprises a first jaw, a secondjaw, a closure drive comprising the first rotary drive member extendingthrough the articulation joint, and a firing drive comprising the secondrotary drive member extending through the articulation joint. The secondrotary drive member can be rotatable independent of the first rotarydrive member. The closure drive can be activated by a closure trigger,for example, whereupon an actuation of the closure drive effects arotation of the first rotary drive member, which transmits a rotarymotion through the articulation joint to a closure screw. The closuredrive further comprises a closure wedge threadably coupled to theclosure screw, wherein the closure wedge is configured to engage thefirst jaw to move the first jaw from an open position to a closedposition upon rotation of the first rotary drive member.

The firing drive can be activated by a firing trigger, for example,which is separate from the closure trigger. The rotation of the secondrotary drive member is separate from the rotation of the first rotarydrive member, and a closure motion is separate and distinct from afiring motion. Activation of the firing drive effects a rotation of thesecond rotary drive member, which transmits a rotary motion through thearticulation joint to a firing screw. The firing drive further comprisesa firing member threadably coupled to the firing screw, wherein thefiring member is configured to camming engage the first jaw and thesecond jaw and to move a cutting member and/or a staple-firing sled uponrotation of the second rotary drive member.

In various instances, at least one component in the powered staplingdevice can be a 3D-printed component. 3D-printed components can beincorporated into an articulation system, a closure/grasping system,and/or a firing system, as further described herein. 3D printingtechnology can be utilized to improve component capabilities in certaininstances. For example, 3D printing can allow the printed component toexhibit metamaterial properties, such that the 3D-printed componentsexhibits greater structural strength and stiffness while allowingprecision in the forming of small detailed features and optimizing otherproperties of the component such as selective flexibility and/orlubrication, for example. Exemplary 3D-printed components for thepowered stapling device are further described herein and include theflexible rotatable drive member(s), e.g. serial 3D-printed universaljoints, the firing member or I-beam, and/or the staple cartridge and/orsub-components thereof. In one instance, the staple cartridge can be acomposite plastic-metal 3D-printed component. 3D printing of variouscomponents and considerations therefor are further described herein.

A method of stapling with such surgical stapling assemblies is alsocontemplated. The method can include obtaining the surgical staplingassembly and activating, by the closure trigger, the closure drive,wherein the closure wedge is configured to engage the first jaw to movethe first jaw from an open position to a closed position upon a rotationof the first rotary drive member. The method can further includesactivating, by the firing trigger, the firing drive, wherein the firingmember is configured to camming engage the first jaw and the second jawand to advance a cutting member and a staple-firing sled during a firingmotion upon a rotation of the second rotary drive member. Variousapplications of 3D-printed components in such assemblies are furtherdescribed herein.

Firing elements and various end effector components are subjected tohigh loads during the firing stroke. The loads imparted may causedeformation and/or wear of the firing elements and/or end effectorcomponents. For example, during a firing stroke, a firing element whichcammingly engages an anvil and an elongate channel of an end effectormay at least partially ride within an anvil slot in the anvil and alongthe bottom of the elongate channel. During firing, the anvil is in itsclosed position, however, as the firing element moves through the endeffector, the anvil may attempt to move away from the elongate channeldue to the forces associated with firing. For example, the force to formthe staples, the force to sever the tissue, and the reactionary forcesfrom the clamped tissue as it is cut and stapled. These forces areimparted onto the firing element during firing and can cause deformationor wear on the firing element and/or other end effector components.

In various embodiments, end effector components may be constructed usingthree dimensional (“3D”) printing to improve component capabilities. Incertain instances, 3D printing can allow components to exhibitmetamaterial properties to aid in lowering the force to fire. Ametamaterial is a synthetic composite material with a structure suchthat it exhibits properties not usually found in natural materials. 3Dprinting is one technique used to create a metamaterial to formstructures with two or more materials. As such, 3D printing allows forthe creation of complex geometries and/or material combinations that mayotherwise be too costly and time consuming to manufacture or may even beimpossible to manufacture absent 3D printing technology.

In various embodiments, a firing element may be 3D printed such that itsmain body acts as a spring to allow the upper and/or lower cam portionsto flex and move to contact the anvil and elongate channel at an angleof reduced resistance.

FIGS. 24 and 25 depict a firing member 41000 for use with a surgicalinstrument, such as the surgical instruments disclosed herein. Thefiring member 41000 is deformable from a first or unloaded configuration(FIG. 24) in the absence of a firing load to a second or expandedconfiguration (FIG. 25) under a firing load. Additional configurations,such as intermediate configurations between the unloaded configurationand the expanded configuration, for example, are also contemplated inresponse to different firing loads. The firing member 41000 comprises aproximal firing bar portion 41100 and a distal head portion 41200extending from the firing bar portion 41100. Specifically, the firingbar portion 41100 includes a distal protrusion 41110 that extends into acutout portion 41250 defined in the proximal end of the distal headportion 41200. The distal protrusion 41110 includes arcuate portions anda blunt distal end for driving engagement with the distal head portion41200. Such an arrangement permits assembly of the firing bar portion41100 to the distal head portion 41200.

The distal head portion 41200 further includes an upper portion 41210and a lower portion 41220 that are movable relative to one another. Thecutout portion 41250 is defined in both the upper and lower portions41210, 41220. As such, the distal end of the firing bar portion 41100 isin engagement with both the upper portion 41210 and the lower portion41220 of the distal head portion 41200. Further, the distal head portion41200 includes a protruding nose 41230 that extends distally. Theprotruding nose 41230 is configured to engage and drive a sled of asurgical staple cartridge distally during a firing stroke, for example.The protruding nose 41230 can be configured to defeat a firing lockoutof a surgical instrument, for example. Further, the distal head portion41200 includes a knife portion or cutting member for severing the tissueof a patient during a firing stroke of the firing member 41000 incertain aspects of the present disclosure.

Further to the above, the distal head portion 41200 comprises a flexibleportion 41240 that connects the upper portion 41210 and the lowerportion 41220 of the distal head portion 41200. Specifically, theflexible portion 41240 comprises a top end 41260 defined in the upperportion 41210, and a bottom end 41270 defined in the lower portion41220. In at least one embodiment, the flexible portion 41240 isembedded into the distal head portion 41200. However, other attachmentarrangements are envisioned for the upper portion 41220, the lowerportion 41220, and the flexible portion 41240. For example, the entiredistal head portion 41200 may be 3D printed having different materialsfor the different portions of the distal head 41200.

In at least one embodiment, the distal head 41200 is comprised of afirst material and the flexible portion 41240 is comprised of a secondmaterial that is different from the first material. For example, theflexible portion 41240 may be comprised of aluminum and the remainder ofthe distal head portion 41200 may be comprised of stainless steel.However, other embodiments are envisioned with different materials forthe distal head portion 41200 and the flexible portion 41240 such asplastic, ABS, rubber, and/or various polymers. In the illustratedembodiment, the flexible portion 41240 is shaped like an “I” having anupright portion and orthogonal flanges at both ends of the uprightportion, however other embodiments are envisioned with differentcross-sectional shapes for the flexible portion 41240.

Further to the above, the distal head portion 41200 comprises an uppercam member defined on the upper portion 41210, and a lower cam memberdefined on the lower portion 41220. The upper and lower cam members areconfigured to cammingly engage a first jaw and a second jaw of an endeffector of a surgical instrument to approximate the first jaw and thesecond jaw relative to one another during a firing stroke. As such, theupper portion 41210 and the lower portion 41220 may separate toaccommodate a transverse load imparted on the distal head portion 41200during the firing stroke. Specifically, as depicted in FIG. 25, a gap41280 may form between the upper portion 41210 and the lower portion41220 of the distal head 41200 during the firing stroke. In theillustrated embodiment, the upper portion 41210 moves away from thelower portion 41240, which is stationary. The distal end of the firingbar 41100 includes an extension 41120, which extends beyond the heightof the upper portion 41210 when the distal head portion 41200 andflexible portion 41240 are undeformed or non-expanded. Further, theextension 41120 of the firing bar 41100 is tall enough to accommodatethe expansion of the distal head 41200. As such, when the distal head41200 is expanded, the extension 41120 of the firing bar 41100 canmaintain driving contact with the proximal end of the distal head 41200.

In any event, other embodiments are envisioned where both the upperportion 41210 and the lower portion 41220 move during a firing stroke inresponse to a firing load. Further, other embodiments are envisionedwhere only the lower portion 41220 moves during a firing stroke.

Further to the above, when the distal head 41200 extends vertically toan expanded configuration, the flexible portion 41240 stretchesvertically while maintaining the connection between the upper and lowerportions 41210, 41220 of the distal head 41200. When the flexibleportion 41240 is stretched, an intermediate portion 41265 of theflexible portion 41240 may neck down or narrow to accommodate atransverse load as depicted in FIG. 25.

FIG. 26 depicts a surgical instrument 42000 comprising an elongate shaft42100, an end effector 42200 extending from the elongate shaft 42100,and a firing member 42300 configured to move relative to the elongateshaft 42100 and the end effector 42200 to perform a firing stroke. Theelongate shaft 42100 may be a closure tube for opening and closing apair of jaws 42240, 42210 of the end effector 42200, for example. Thefiring member 42300 comprises a proximal firing bar portion 42310 and adistal head portion 42320 extending therefrom. Specifically, theproximal firing bar portion 42310 includes a distal protrusion 42312that extends into a cutout 42336 defined in the proximal end of thedistal head portion 42320. Such an arrangement facilitates the assemblyof the proximal firing bar portion 42310 to the distal head portion42320.

Further to the above, the distal head portion 42320 is a two-partassembly formed from an upper portion 42330 and a lower portion 42340that are movable relative to one another. The upper portion 42330comprises a distally-protruding lower foot 42334 and the lower portion42340 comprises a proximally-protruding upper foot 42342 positioned tointeract and selectively interlock with the distally-protruding lowerfoot 42334. An opening 42400 is defined between the distally-protrudinglower foot 42334 and the proximally-protruding upper foot 42342 when theupper portion 42330 and the lower portion 42340 are in a collapsedconfiguration, as depicted in FIG. 26. The opening 42400 permits theupper portion 42330 to move relative to the lower portion 42340, to anextent, during a firing stroke of the distal head portion 42320, asdiscussed in greater detail below.

Further to the above, the distally-protruding lower foot 42334 extendsinto a pocket, or cavity 42346, in the lower portion 42340. The cavity42346 defines a flange 42348 on the proximal end of the lower portion42340. The flange 42348 extends toward the upper portion 42330 andprevents the distally-protruding lower foot 42334 of the upper portion42330 from becoming detached from the lower portion 42340. Specifically,the opening 42400 height is smaller than the height of the flange 42348and, thus, the upper portion 42330 and the lower portion 42340 areprevented from detaching in the longitudinal direction.

Further to the above, the upper portion 42330 and the lower portion42340 of the distal head portion 42320 can be connected via a flexibleattachment member, such as the flexible portion 41240 of FIG. 24, forexample, in certain instances. Further, in at least one aspect, theupper portion 42330 and the lower portion 42340 of the distal headportion 42320 can comprise two completely separate components that arenot attached, but are held together due to the internal geometry of theelongate shaft 42100 and end effector 42200.

Further to the above, The upper portion 42330 comprises a first cammember configured to cammingly engage the first jaw 42240 of the endeffector 42200 during a firing stroke, and the lower portion 42340comprises a second cam member configured to cammingly engage the secondjaw 42210 of the end effector 42200 during the firing stroke. As such,the first cam member and the second cam member are configured toapproximate the first jaw 42240 and the second jaw 42210 of the endeffector 42200 during the firing stroke. In the illustrated embodiment,the first jaw 42240 comprises a movable anvil, and the second jaw 42210comprises an elongate channel configured to receive a staple cartridge42220. The anvil 42240 is movable relative to the elongate channel 42210between an open position and a closed position. Further, the firingmember 42300 is configured to move a sled 42230 of the staple cartridge42220 through the end effector 42200 to eject staples from the staplecartridge 42220.

In use, as the firing member 42300 distally advances from the unfiredposition depicted in FIG. 26, the distal head portion 42320 advancesbeyond the distal end of the elongate shaft 42100, which can allow forexpansion of the distal head portion 42320 under certain firing loads.The distal head portion 42320 advances into the end effector 42200 suchthat the upper cam member engages the anvil 42240 and the lower cammember engages the elongate channel 42210. As such, the first cam memberon the upper portion 42330 is in camming engagement with the movableanvil 42240 during the firing stroke, and the second cam member on thelower portion 42340 is in camming engagement with the elongate channel42210 during the firing stroke.

The upper portion 42330 and the lower portion 42340 are capable ofseparating or moving farther apart vertically during the firing stroke.For example, when the anvil 42240 is in its closed position and thefiring stroke has commenced, forces due to staple firing, cutting,and/or patient tissue may deflect or move the anvil 42240 away from theelongate channel 42210. The expansion of the distal head portion 42320can accommodate such movement or deflection. In certain instances, theexpansion of the firing member 42320 can accommodate entry of the uppercam member on the upper portion 42330 into an anvil channel of the anvil42200 if the anvil channel is misaligned. Further, the expansion of thedistal head portion 42320 is limited by the distally-protruding lowerfoot 42334 and the proximally-protruding upper foot 42342, which aredrawn closer together to close the space 42400 therebetween andeventually engage one another to limit the extent of expansion of thedistal head portion 42320.

Further to the above, after the distal head portion 42320 has beendistally advanced and expanded, the distal head portion 42320 can beretracted back to the home or unfired position illustrated in FIG. 26.During retraction, a first cam surface 42338 on the upper portion 42330engages a second cam surface 42120 on the distal end of the elongateshaft 42100. The first and second cam surfaces 42338, 42120 interact tocompress the distal head 42320 into its non-expanded state (FIG. 26).

Further to the above, the lower portion 42340 of the distal head portion42320 comprises a cutout portion 42344 defined in the distal end of thelower portion 42340. The cutout portion 42344 is configured to receive aproximal nose portion 42232 of the sled 42230 therein. As such, a distaladvancement of the distal head portion 42320 will advance the sled 42230through the staple cartridge 42220 to eject the staples. Further, thedistal head portion 42320 comprises a knife portion 42332 configured tosever the tissue of a patient during the firing stroke.

FIGS. 27 and 28 depict a stapling attachment 43000 for use with asurgical instrument, such as those described herein. The staplingattachment 43000 comprises an elongate shaft 43100 attachable to ahandle and/or housing, and an end effector 43200 extending from theelongate shaft 43100. The end effector 43200 comprises a first jaw, oranvil 43210, and a second jaw, or elongate channel 43220. The anvil43210 is movable relative to the elongate channel 43220 between an openposition and a closed position in response to a closure motion from aclosure system. The anvil 43210 comprises landing portions 43212 on itsproximal end. Further, a medium and/or low durometer material 43214extends from the landing portion 43212. The low durometer material 43214can comprise rubber, plastic, a polymer and/or any other suitablematerial, for example. The material 43214 has a lower durometer than thelanding portion 43212. In one aspect, the landing portion 43212 can bemetal, and the material 43214 can be rubber, for example.

Further to the above, the elongate channel 43220 is configured toreceive a staple cartridge 43230 therein. The staple cartridge 43230comprises a proximal cartridge tail 43232 with substantially flatportions on both sides of a cartridge slot 43234. Typically, thecartridge tail 43232 is configured to interact with the landing portions43212 of the anvil 43210 when the anvil 43210 is in its closed position.In the illustrated embodiment, the low durometer material 43214 acts asa semi-compressible material between the landing portions 43212 of theanvil 43210 and the cartridge tail 43232. As such, the anvil 43210 iscapable of floating relative to the staple cartridge 43230 in responseto the forces exerted by the closure system and/or the firing system.Specifically, due to the compressible nature of the low durometermaterial 43214, the anvil 43210 can flex and/or deflect relative to thestaple cartridge 43230 more than would be possible without the lowdurometer material 43214 present on the landing portions 43214.

Other embodiments are envisioned where the low durometer material 43214is defined as part of the anvil 43210 and flush with the landingportions 43212 of the anvil 43210. In such an arrangement, the lowdurometer material 43214 may allow for over-closing of the anvil 43210relative to the staple cartridge 43230. Specifically, a firing memberengages the anvil slot 43216 and the elongate channel 43220 to close theanvil 43200 relative to the staple cartridge 43230 during an initialclosing operation. During the initial closing operation of the anvil43200, the compressible low durometer material 43214 flush with thelanding portions 43212 can abut and cause interference with the rigidcartridge tail 43232 of the staple cartridge 43230. Because the lowdurometer material 43214 is compressible, the proximal portion of theanvil 43200 is capable of flexing to overcome the interference betweenthe landing portions 43212 and the cartridge tail 43232. As the firingmember advances through the staple cartridge 43230, the low durometermaterial 43214 may further compress against the rigid cartridge tail43232. The two surfaces 43214, 43232 can move past the point ofinterference to allow the firing member to complete the firing strokewithout binding.

Further to the above, the low durometer material 43214 may be morecompressible than the anvil 43210 and/or the cartridge 43230. Further,the low durometer material 43214 may reduce the forces on a firingmember which travels through the anvil 43210 and the staple cartridgeslot 43234. Specifically, a firing member with an upper and lower cammember, such as those described herein, can move within the end effector43200. For example, the upper cam of the firing member moves throughanvil slot 43216. Due to the compressibility of the low durometermaterial 43214, the anvil slot 43216 can flex relative to the staplecartridge 43230. As such, less force will be exerted on the upper cammember of the firing member during closing and/or firing as compared toif the low durometer material 43214 were not present.

Further to the above, embodiments are envisioned which incorporate thelow durometer material 43214 and the expanding firing members 41000,42320 of FIGS. 24-26 into an end effector. The compressibility of thelow durometer material 43214 of an anvil, for example, in combinationwith the expanding capabilities of the firing members 41000 or 42320,for example, can provide an end effector with greater variability duringthe firing stroke. Specifically, the low durometer material 43214 canallow the anvil to float more relative to the cartridge, and theexpanding firing members 41000, 42320 can allow for greater leeway inalignment between the firing member flanges and the anvil slot.

In various embodiments, firing members, (e.g., I-beams or E-beams) canbe constructed to have complex 3D printed geometries incorporated intothe main body, which can act as a spring and allow the upper cam portionto flex and move with the anvil ledge to an angle of reduced or leastresistance. Such geometric complex printed structures allow formetamaterial behaviors. For example, a metal I-beam could have portionsthat act as a solid metal structure and alternative portions havinggeometries that are designed to allow for greater bending and/orstretching to permit the I-beam to focus its deflection in a locationand/or orientation to align the I-beam to the use and/or load. Exemplaryembodiments of such I-beams are discussed in greater detail below.

FIG. 29 depicts a firing member 44000 comprising a body portion 44100, apair of upper cam members 44140 extending laterally from both sides ofthe body portion 44100, and a pair of lower cam members 44150 extendinglaterally from both sides of the body portion 44100. The upper cammembers 44140 are configured to cammingly engage an upper jaw, or anvil,of an end effector during a firing stroke, and the lower cam members44150 are configured to cammingly engage a lower jaw, or elongatechannel of the end effector during the firing stroke. The elongatechannel is configured to receive a staple cartridge including staplesthat can be ejected when the firing member 44000 is advanced within thestaple cartridge. Exemplary jaws, anvil, and staple cartridges for usewith the firing member 44000 are further described herein.

Further to the above, the body portion 44100 comprises a longitudinalopening 44110 extending through the body portion 44100 and defining alongitudinal axis LA. The body portion 44100 further comprises a distalnose portion 44130 extending distally from the body portion 44100. Thelongitudinal opening 44110 is configured to receive a rotary firingdriver, such as firing screw 261 (see, e.g. FIG. 16) described above.The body portion 44100 further comprises a cutout region 44120configured to receive a firing drive nut 44200. The firing drive nut44200 is configured to threadably engage the rotary firing driver toconvert rotary motion of the rotary firing driver into translation ofthe firing member 44000. The firing drive nut 44200 comprise a pair oflaterally-extending members 44210 that extend from both sides of thefiring drive nut 44200. The pair of laterally-extending members 44210are aligned with the pair of lower cam members 44150. As such, the cammembers 44210, 44150 cooperate to cammingly engage the lower jaw of theend effector during the firing stroke.

Further to the above, the firing member 44000 further comprises flexibleportions 44160 positioned intermediate the body portion 44100 and thepair of upper cam members 44140. In other words, the flexible portions44160 attach at least a portion of the upper cam members 44140 to thebody portion 44100. As can be seen in FIG. 31, the flexible portions44160 comprise a three-dimensional lattice comprising an array ofcavities, gaps, and/or cutouts. The array of cavities form a pluralityof arcuate bars 44162 arrange in an array. The flexible portion 44160comprises an overall cross-sectional density that is reduced compared tothe adjacent upper cam member 44140 and the body portion 44100. As such,the flexible portions 44160 can flex, bend, and/or deflect a greateramount than the adjacent upper cam member 44140 and the body portion44100. As can be seen in FIG. 31, the arcuate bars 44162 andcorresponding cutout regions are symmetrical about the body portion44100. However, other embodiments are envisioned where the arcuate bars44162 are of varying shapes and sizes on the same side and/or or onopposite sides of the body portion 44100. In certain instances, thearray of cavities can form linear bars, for example. In at least oneembodiment, the flexible portion 44160 comprises a three-dimensionalhoneycomb lattice, for example. The three-dimensional lattice of theflexible portions 44160 can have a reduced density in comparison toadjacent portions. Moreover, the flexible portions 44160 can have asignificantly reduced infill percentage in comparison to adjacentportions.

Further to the above, as can be seen in FIG. 31, the flexible portions44160 extend longitudinally along only a portion of the upper cammembers 44140 from the distal end of the upper cam members 44140 andterminate in an intermediate portion of the upper cam members 44140. Assuch, the distal end of the upper cam members 44140 is more flexiblethan the proximal end of the upper cam members 44140. Other embodimentsare envisioned where the flexible members 44160 extend along the entirelength of the upper cam members 44140 and/or only at the proximal end ofthe upper cam members 44140. Further still, other embodiments areenvisioned where the flexible portions 44160 are in the middle of theupper cam members 44140 with more rigid portions at the proximal anddistal ends.

Further to the above, in at least one embodiment, the firing member44000 may be constructed using a 3D printing process. Infill and solidwall parts are traditionally used to fabricate objects that arelightweight and strong. 3D printed parts are manufactured with aspecific infill percentage. The printing process uses a crosshatch orother pattern for interior surfaces to form cells within the infillportion of the 3D printed part. The density of this pattern is referredto as the infill percentage. For example, it is common to have 1-2 mmthick walls, and to have 25-35% of the part solid inside of the walls.When building parts with powder based processes, such as 3D printing, itis important to note that powder must have escape holes to ensure powderreclamation after the part is fabricated. Infill for parts can be 2Dlike a honeycomb, or 3D like a gyroid. Different patterns have differentstrength profiles. For example, patterns with larger cells can be moreflexible than patterns with smaller cells. Due to the freedom ofgeometry, the geometry can be variably thickened and thinned to ensurethat flexion can occur at a desired location and a desired amount.

Different geometries and infill percentages could be used at differentlocations in the firing member 44000 to achieve different degrees ofdeformation and/or predispositions to different directions ofdeformation. In certain instances, the leading end of the upper camportion 44140 can have a different infill percentage or infillmatrix/geometry than adjacent portions of the firing member 44000 tomaintaining the rigidity of the proximal end of the upper cam member44140, as depicted in FIG. 31. An increased deflection of the leadingedge of the upper cam member 44140 can facilitate alignment of the uppercam member 44140 with the anvil ledge at the outset of the firingmotion, which can avoid jamming or binding of the firing member incertain instances, such as when thick and/or tough tissue is clampedbetween the jaws. Other embodiments are envisioned where the middle ofthe upper cam member 44140 is flexible with both of the ends more rigid.As such, by varying the firing member geometry with 3D printing, thelocation and amount of flexion can be controlled based on the amount offorce anticipated.

FIGS. 32 and 33 depict a firing member 45000 comprising a body portion45100, a pair of upper cam members 45140 extending laterally from bothsides of the body portion 45100, and a pair of lower cam members 45150extending laterally from both sides of the body portion 45100. The uppercam members 45140 are configured to cammingly engage an upper jaw, oranvil, of an end effector during a firing stroke, and the lower cammembers 45150 are configured to cammingly engage a lower jaw, orelongate channel of the end effector during the firing stroke. Theelongate channel is configured to receive a staple cartridge includingstaples that can be ejected when the firing member 44000 is advancedwithin the staple cartridge. Exemplary jaws, anvil, and staplecartridges for use with the firing member 45000 are further describedherein.

Further to the above, the body portion 45100 comprises a longitudinalopening 45110 extending through the body portion 45100, similar to thelongitudinal opening 44110 (see FIG. 29). The longitudinal opening 45110is configured to receive a rotary firing driver, such as firing screw261 (see, e.g. FIG. 16) described above. The body portion 45100 furthercomprises a distal nose portion 45130 extending distally from the bodyportion 45100. The body portion 45100 further comprises a cutout region45120 configured to receive a firing drive nut 45200. The firing drivenut 45200 is configured to threadably engage the rotary firing driver toconvert rotary motion of the rotary firing driver into translation ofthe firing member 45000. The firing drive nut 45200 comprise a pair oflaterally-extending cam members 45210 that extend from both sides of thefiring drive nut 45200. The pair of laterally-extending cam members45210 are aligned with the pair of lower cam members 45150. As such, thecam members 45210, 45150 cooperate to cammingly engage the lower jaw ofthe end effector during the firing stroke.

Further to the above, the firing member 45000 further comprises aflexible portion 45160 positioned intermediate the upper cam members45140 and the lower cam members 45150, 45210. The flexible portion 45160comprises a first plurality of arcuate slots 45170 extending laterallythrough the body portion 45100, and a second plurality of arcuate slots45180 extending laterally through the body portion 45100. In theillustrated embodiment, the first plurality of arcuate slots 45170 arecurved in a direction which resembles a backward C-shape, and the secondplurality of arcuate slots are curved in the opposite direction whichresembles a forward C-shape. However, other embodiments are envisionedwith different curvatures or combination of curvatures for the arcuateslots 45170. Further, in the illustrated embodiment five first arcuateslots 45170 and five second arcuate slots 45180 are depicted, however,other embodiments are envisioned with more or less than five arcuateslots for each of the first plurality or arcuate slots 45170 and each ofthe second plurality of arcuate slots 45180.

In any event, the body portion 45100 further comprises a first cutoutregion 45175 on its distal end that is defined by the first plurality ofarcuate slots 45170, and a second cutout region 45185 on its proximalend that is defined by the second plurality of arcuate slots 45180. Thearcuate slots 45170, 45180 and the cutout regions 45175, 45185 permitthe firing member 45000 to flex and/or deflect when a load is applied tothe firing member 45000, as discussed in greater detail below.

Referring primarily to FIG. 33, an anvil channel or anvil ledge 45300and an elongate channel 45400 for receiving a staple cartridge aredepicted in dashed lines for the purpose of simplicity. In use, when thefiring member 45000 is driven within an end effector, the upper cammembers 45140 are configured to cammingly engage the anvil (i.e., ridealong the anvil ledge 45300) during the firing stroke. Further, thelower cam members 45150, 45210 are configured to cammingly engage thebottom of the elongate channel 45400 during the firing stroke. Duringthe firing stroke of the firing member 45000, the upper cam members45140 may experience a lateral force F applied by the anvil ledge 45300when the anvil ledge 45300 moves away from the elongate channel 45400.For example, the lateral force F may be due to clamping of patienttissue, firing of the staples, or cutting of the patient tissue. In atleast one embodiment, the lateral force F may be applied to the uppercam members 45150 upon entry into the anvil channel, for example. In anyevent, the firing member 45000 is configured to flex and/or deflect dueto the flexible portion 45160 during the firing stroke. Specifically, inFIG. 32 the firing member 45000 is in a relaxed state corresponding toan unloaded configuration, and in FIG. 33 the firing member 45000 is inan unrelaxed, or deflected state corresponding to a loadedconfiguration.

Further to the above, due to the lateral force F applied to the uppercam members 45140, the upper cam members 45140 rotate in a clockwisedirection which causes the flexible portion 45160 and the body portion45100 to flex and/or deflect to enable the firing member 45000 to changeshape based on the load applied. Specifically, the first plurality ofarcuate slots 45170 are configured to stretch and the second pluralityof arcuate slots 45180 are configured to compress when the lateral forceF is applied. Moreover, the first cutout region 45175 elongates and thesecond cutout region 45185 compresses when the lateral force F isapplied. As such, the firing member body 45100 can flex and/or deflectto accommodate the lateral force F.

Further to the above, during use, the upper cam members 45140 areconfigured to ride along the anvil ledge 45300 within a longitudinalanvil slot. Upon initial entry of the upper cam members 45140 into theanvil slot, the upper cam members 45140 may be misaligned due to thevarying amounts of tissue (i.e., thick and thin tissue) grasped betweenthe jaws. As such, the flexible portion 45160 permits the upper cammembers 45140 to flex and/or deflect to properly align the upper cammembers 45140 with the anvil slot, for example. Further, the varyingamounts of tissue grasped between the jaws may cause the anvil ledges45300 to move away from the elongate channel 45400 during a firingstroke of the firing member 45000. As such, the upper cam members 45140may become misaligned with the anvil slot during firing. However, theflexible portion 45160 permits the upper cam members 45140 to flexand/or deflect to compensate for the varying amounts of tissue toprevent the upper cam members 45140 from jamming within the anvil slotwhen the upper cam members 45140 are not properly aligned within theanvil slot.

Further to the above, in at least one embodiment, the firing member45000 can comprise a longitudinal slot extending through the flexibleportion 45160 to permit one lateral side of the firing member 45000 toflex at least partially independent of another lateral side of thefiring member 45000. The longitudinal slot may be similar tolongitudinal slot 46170 (see FIG. 34) discussed in greater detail below,for example.

FIGS. 34-36 depict a firing member 46000 comprising a body portion46100, a pair of upper cam members 46140 extending laterally from bothsides of the body portion 46100, and a pair of lower cam members 46150extending laterally from both sides of the body portion 46100. The uppercam members 46140 are configured to cammingly engage an upper jaw, oranvil, of an end effector during a firing stroke, and the lower cammembers 46150 are configured to cammingly engage a lower jaw, orelongate channel of the end effector during the firing stroke. Theelongate channel is configured to receive a staple cartridge includingstaples that can be ejected when the firing member 46000 is advancedwithin the staple cartridge. Exemplary jaws, anvil, and staplecartridges for use with the firing member 46000 are further describedherein.

Further to the above, the body portion 46100 comprises a longitudinalopening 46110 extending through the body portion 46100 and defining alongitudinal axis LA. The longitudinal opening 46110 is configured toreceive a rotary firing driver, such as firing screw 261 (see, e.g. FIG.40) described above. The body portion 46100 further comprises a distalnose portion 46130 extending distally from the body portion 46100. Thebody portion 46100 further comprises a cutout region 46120 configured toreceive a firing drive nut 46200. The firing drive nut 46200 isconfigured to threadably engage the rotary firing driver to convertrotary motion of the rotary firing driver into translation of the firingmember 46000. The firing drive nut 46200 comprise a pair oflaterally-extending cam members 46210 that extend from both sides of thefiring drive nut 46200. The pair of laterally-extending cam members46210 are aligned with the pair of lower cam members 46150. As such, thecam members 46210, 46150 cooperate to cammingly engage the lower jaw ofthe end effector during the firing stroke.

Further to the above, the firing member 46000 further comprises aflexible portion, or lattice portion, 46160 positioned intermediate theupper cam members 46150 and the lower cam members 46150. In theillustrated embodiment, the lattice portion 46160 is bifurcated by alongitudinal slot 46170 which extends parallel to the longitudinal axisLA. The longitudinal slot 46170 extends through the body portion 46100from the proximal end to the distal end. As such, the lattice portion46160 is divided into a first side 46180 and a second side 46190. Thefirst side 46180 of the lattice portion 46160 comprises a plurality ofslots 46182 oriented transverse to the longitudinal axis LA in a firstdirection. The second side 46190 of the lattice portion 46160 comprisesa plurality of slots 46192 oriented transverse to the longitudinal axisLA in a second direction that is opposite the first direction. Theplurality of slots 46182, 46192 reduce the overall cross-sectionaldensity of the firing member 46000 within the lattice portion 46160. Inother words, the lattice portion 46160 is less dense (e.g. lower infillpercentage) than the adjacent portions of the body portion 46100 of thefiring member 46000. Further, the longitudinal slot 46170, whichbifurcates the lattice portion 46160, permits the first side 46180 ofthe lattice 46160 to slide past the second side 46190 of the lattice46160, and vice versa, and/or permits the first side 46180 of thelattice 46160 to stretch vertically while the second side 46190 iscompressed vertically, or vice versa. Without the longitudinal slot46170, sliding and deflection of the first and second sides 46180, 46190relative to one another would be limited.

Further to the above, the first side 46180 comprises a notch 46185 onthe proximal end of the body portion 46100, and the second side 46190comprises a notch 46195 on the proximal end of the body portion 46100.The notches 46185, 46195 provide greater flexion and/or deflection ofthe proximal end of the body portion 46100 as compared to the distal endof the body portion 46100. Moreover, in the illustrated embodiment, thenotches 46185, 46195 are positioned on the proximal end of the bodyportion 46100. However, other embodiments are envisioned where thenotches 46185, 46195 are positioned on the distal end of the bodyportion 46100 for the opposite effect. Further still, other embodimentsare envisioned with notches on the proximal and distal ends of the bodyportion 46100, see FIG. 38 and accompanying description below.

In use, when the firing member 46000 is advanced into an end effector,the upper cam members 46140 engage an upper jaw, or anvil of the endeffector, and the lower cam members 46150, 46210 engage a lower jaw, orelongate channel of the end effector. As such, the lattice portion 46160is configured to permit the upper cam members 46140 and the lower cammembers 46150, 46210 to flex and/or deflect relative to the body portion46100 to accommodate lateral forces during the firing stroke.

The body portion 46100 and the lattice portion 46160 can be constructedof varying geometries and materials to accommodate a desired stressprofile within the firing member 46000 during the firing stroke. Forexample, the firing member 46000 can be constructed using 3D printing,or an equivalent process. In at least one embodiment, the body portion46100 is 3D printed as a unitary piece with the body portion comprisinga first material and the lattice portion 46160 comprising a secondmaterial that is different from the first material. Further, the firstmaterial may comprise a first density and the second material cancomprise a second density that is different from the first density.

Further to the above, 3D printing generally produces structures thathave some amount of open space (i.e., they are not completely solid on amicro level). As discussed above, the 3D printing process uses acrosshatch or other pattern for interior surfaces housed within moresolid wall structures. The density of this pattern within the solidwalls is referred to as the infill percentage. The infill percentage canbe varied throughout the 3D printing process to produce a componenthaving different infill percentages for different portions of thecomponent. If different infill portions comprise different infillpercentages, they inherently comprise different densities on a microlevel. In other words, the different infill portions can be varied toproduce different micro densities within a component.

Further to the above, other embodiments are envisioned where the infillpercentage is uniform throughout the entire part. In such instances,flexibility can be built into the part from macro-geometry aspects, suchas slots, cutouts, holes etc. upon which the 3D build is built around.For example, the firing member 46000 may comprise an entirely uniforminfill percentage. In such an instance, the slots 46182, 46192 definebar structures in between the slots 46182, 46192, and the bar structureswould comprise the same infill percentage as the rest of the firingmember 46000, for example.

FIG. 37 depicts a graphical representation 47000 of the forces impartedon the firing member 46000 during a firing stroke. In the illustratedembodiment, the larger the force exerted on the firing member 46000 thedarker the shading. The forces are shown in the legend in FIG. 37 aspounds per square inch (PSI). In the illustrated embodiment, a 150 poundload on the distal end of the firing member 46000 resulted in 1 degreeof bending during the finite element analysis simulation.

FIGS. 38 and 39 depict a firing member 48000 similar in many aspects tothe firing member 46000 and with the differences discussed herein. Thefiring member 48000 comprises a flexible portion, or lattice portion48160. The lattice portion 48160 is bifurcated by a longitudinal slotthat divides the lattice portion 48160 into a first side 48180 andsecond side 48190. The first side 48180 comprises a proximal notch 48182defined in the proximal end of the firing member 48000, and a distalnotch 48184 defined in the distal end of the firing member 48000. Thenotches 48182 and 48184 are V-shaped or triangular cutouts. The proximalnotch 48182 is larger along the upper edge, while the distal notch 48184is larger along the lower edge. The second side 48190 comprises proximaland distal notches that are opposite the proximal notch 48182 and thedistal notch 48184. As such, the first side 48180 of the lattice portion48160 is a flipped mirror image of the second side 48190 of the latticeportion 48160. Similar to the firing member 46000, the firing member48000 comprises a plurality of slots oriented in the lattice portion48160. Specifically, the first side 48180 comprises a plurality of slots48186 oriented in a first direction transverse to longitudinal axis LAof the firing member 48000. Further, the second side 48190 comprises aplurality of slots 48196 oriented transverse to the longitudinal axis LAin a second direction opposite the first direction.

FIG. 40 depicts a model of a flexible portion 49000 configured for usewith a firing member of a surgical instrument, such as those firingmembers described herein. The flexible portion 49000 is configured toflex front-to-back and side-to-side to accommodate a loading force onthe firing member during a firing stroke. The flexible portions 44160,45160, 46160, 48160 described herein can be configured to flex as shownin FIG. 40, resulting in front-to-back and side-to-side flexing of theI-beam as well. Embodiments are envisioned where the flexible portion49000 is part of, or takes the place of, the flexible portions 44160,45160, 46160, 48160 in the firing members described herein. The flexibleportion 49000 is configured to transition from a relaxed state 49100(shown in phantom lines) to a flexed, or deflected state 49100′ (shownin solid lines) when a force is imparted onto the flexible portion49000.

In the illustrated embodiment, the force applied is imparted onto anupper member 49100 of the flexible member 49000 while a base 49120 ofthe flexible member 49000 is held stationary. The upper member 49100 andthe base 49120 are connected by a first vertical member 49130 and asecond vertical member 49140 which crisscross to form anX-configuration. In use, when a force is applied to the upper member49100, the upper member 49100 transitions to a deflected state 49110′,the first vertical member 49130 transitions to a deflected state 49130′,and the second vertical member 49140 transitions to a deflected state49140′. The first and second vertical members 49130, 49140 can bedeflected to accommodate various loads applied to the upper member49100.

It should be appreciate that any of the discrete features of theflexible portions 44160, 45160, 46160, 48160, 49000 can be used incombination with each other. For example, the flexible portions 44160positioned between the upper cam member 44140 and the body portion 44100may be incorporated into the firing members 45000, 46000, and/or 48000.Moreover, the flexible portions 44160 may be incorporated into any ofthe lower cam members of firing members 44000, 45000, 46000, 48000,49000 to provide for greater flexion of the lower cam members in certaininstances.

3D printing may be utilized in a similar approach for various instrumentcomponents described herein, among others. For example, to accommodate arotary drive screw in an elongate channel of a surgical instrument, theelongate channel may comprise a distal support bearing or support washerto support the distal end of the rotary drive screw. In at least oneembodiment, the distal support bearing could be 3D printed to include acompressible portion that, when compressed in a first direction expandsin a second direction that is transverse to the first direction toincrease the bearing surface between the distal support bearing and therotary drive screw. As a result, the coupling between the rotary drivescrew and the distal support bearing is improved in certain instancesdue to a decrease in the bearing loads achieved by increasing thebearing surface area.

Channel retainers and various end effector components are subject tohigh deflection and longitudinal loads during operation of a surgicalinstrument. Standard materials for these components consist of aluminumand stainless steel which have limited stretch and deflectioncapabilities. For example, 250 to 300 pounds of force can be appliedlongitudinally to a channel retainer during a surgical actuation and anacceptable longitudinal flex can be less than 0.08 inches.

A composite component can include different materials for differentportions to obtain complex part geometries, such as interlockingfeatures, alignment keyways, or open sliding passages, for example, witha first material (e.g. plastic) while also maintaining appropriatestrength, stiffness, and/or rigidity with a second material (e.g. metal)to support the longitudinal stress and strain loads during a surgicalactuation. Metal portion(s) in a composite component can be flexible inone plane but rigid or stiff in another. For example, metal portions canpermit lateral flexing but limit longitudinal stretching. Moreover,plastic material can act as a gap filler and interlocking substancebetween the metal substrates, while also allowing feature-rich, complexgeometries. For example, a low durometer or flexible material such asplastic may be used as a body portion for an end effector component. Theplastic body portion can comprise metal substrate portions definedtherein to bear the loading forces during operation while the plasticbody provides keying and alignment features. Such a laminate componentcan be constructed with 3D printed plastic and metal substrate inserts.

For example, a channel retainer for use with a surgical device cancomprise a first metal substrate, a second metal substrate interlockingwith the first metal substrate, and a plastic portion built around thefirst metal substrate and the second metal substrate. The channelretainer is positioned between a handle and an end effector of thesurgical device. Further, the channel retainer can comprise alignmentand connection features built into the plastic body to facilitateattachment to the surgical device.

FIGS. 41-43 depict a channel retainer 50000 for use with a surgicalinstrument, such as those described herein. In various embodiments, theproximal end of the channel retainer 50000 can be connected to a handleand/or housing of a surgical instrument and the distal end of thechannel retainer 50000 can be connected to an articulation joint and/orend effector of a surgical instrument. The channel retainer 50000 actsas a longitudinal spine portion of the surgical instrument in suchinstances. Further, the channel retainer 50000 can support articulationactuators, firing actuators, and/or closure actuators of the surgicalinstrument. In at least one embodiment, the channel retainer 50000 bearsthe load of a closure tube which surrounds the channel retainer 50000.As the closure tube advances to effectuate an end effector, forces areexerted onto the channel retainer 50000. As such, the channel retainer50000 can stretch and deflect due to the loading forces exerted by theclosure tube.

Further to the above, the proximal end of the channel retainer 50000comprises notches 50130 which facilitate attachment of the channelretainer 50000 to the handle and/or housing of a surgical instrument.The distal end of the channel retainer 50000 comprises notches 50120which facilitate attachment of the channel retainer to an articulationjoint and/or end effector of a surgical instrument. However, otherembodiments are envisioned with different attachment features forconnecting the channel retainer 50000 to the surgical instrument.

Further to the above, the channel retainer 50000 comprises a bodyportion 50100, first substrate portions 50300, and second substrateportions 50400. The channel retainer 50000 further comprises alongitudinal slot 50110 defined therein for receiving various actuatorsof a surgical instrument. For example, a firing member extending from ahandle or housing of a surgical instrument can extend within thelongitudinal slot 50110. In any event, the longitudinal slot 50110splits the channel retainer 50000 in half with the first and secondsubstrate portion 50300, 50400 positioned on each side of the slot 50110(i.e., the channel retainer 50000 is symmetrical). In at least oneembodiment, the body portion 50100 is 3D printed with the first andsecond substrate portions 50300, 50400 defined therein. In other words,the body portion 50100 is built around the first and second substrateportions 50300, 50400. In at least one embodiment, the body portion50100 is comprised of plastic and the substrate portions 50300, 50400are comprised of metal. The substrate portions 50300, 50400 can becomprised of stamped metal plates, for example. Other embodiments areenvisioned where the substrate portions 50300, 50400 comprises materialsthat are more rigid and/or dense than the body portion 50100, forexample.

As illustrated in FIG. 43, the first substrate portions 50300 arepositioned within the body portion 50110 at the proximal end. Each firstsubstrate portion 50300 comprises a first lateral flange 50310 at itsdistal end. The first lateral flanges 50310 extend toward thelongitudinal slot 50110. The second substrate portions 50400 arepositioned within the body portion 50100 and each comprises a firstopening 50410 at their proximal end and a second opening 50420 at theirdistal end. The first and second substrates 50300, 50400 are positionedsuch that the first opening 50410 receives the first lateral flange50310 to operably connect the first substrate portion 50200 and thesecond substrate portion 50400 within the body portion 50100. In otherwords, the first and second substrate portions 50300, 50400 are at leastpartially embedded and/or encapsulated within the body portion 50100.

These substrates can form a multi-interlocking load sharing assemblycomprised of stamped components within the 3D-printed assembly. Incertain instances, interlocking of stamped components within a3D-printed assembly can be utilized to combine components whereinjection molding is not a viable alternative due to the shrinking ofthe composite material over elongated metal components during a moldingprocess, which can result in a buildup of internal stresses and shearfeatures within the assembly. For example, elongate assemblies, such aschannel retainers, for example, may be better suited to 3D printingaround interlocking metal components.

Further to the above, each of the first substrate portions 50300comprise a second lateral flange 50320 positioned at their proximal endand extending away from the longitudinal slot 50110. The second lateralflanges 50320 are built and/or embedded into the body portion 50100 suchthat they extend behind the proximal notches 50310 defined in the bodyportion 50100. As such, the first substrate portions 50300 are at leastpartially restricted from moving longitudinally within the body portion50100 due to their engagement with the proximal notches 50310. Further,the alignment notches 50310 may be used to attach and align the channelretainer 50000 within a handle or housing of the surgical instrument. Assuch, the first substrate portions 50300 within the proximal end provideadditional support to the channel retainer 50000 to facilitateattachment to a surgical instrument. Other embodiments are envisionedwith the first substrate portions 50300 at both the proximal and distalends to facilitate attachment to a surgical device. In at least oneembodiment, the body portion 50100 comprises a keying feature, analignment feature, and/or an interlocking feature for use with asurgical instrument.

The first and second substrate portions 50300, 50400 can comprise morerigid metallic materials to bear the loading and stretch forces that thechannel retainer 50000 experiences during operation of the surgicalinstrument.

Further to the above, the first substrate portion 50300 and/or thesecond substrate portion 50400 comprise flexible circuit boards and/orother integrated electronics supported or affixed thereto. Duringmanufacture, the 3D printing material of the body portion 50100 can beoverprinted around the substrate portions 50300, 50400 without directlyaffixing the build material to the electronics of the substrate portions50300, 50400. By preventing direct application of the 3D build materialonto the substrate portions 50300, 50400, the risk of damage to thesubstrate portions 50300, 50400 and their electronic components isreduced. For example, referring primarily to FIG. 43, there are variousgaps 50500 between the substrate portions 50300, 50400 and the bodyportion 50100. As such, the channel retainer 50000 is constructed suchthat at least portions of the substrate portions 50300, 50400 are not 3Dprinted directly thereon. Electronic components can be positioned inlocations that are not directly 3D printed on, which can inhibit heattransfer and/or inadvertent damage to the electronic components due tolocalized heat. However, other embodiments are envisioned where thesubstrate portions 50300, 50400 are completely encapsulated andsurrounded by the 3D build material of the body portion 50100.

As discussed above, the channel retainer 50000 may be constructed via 3Dprinting. For example, before the 3D build begins, metal substrates suchas substrate portions 50300, are introduced upon which the 3D plasticbuild will be attached. Partially through the 3D build, the build couldbe stopped with standing alignment features to permit the creation of aperimeter build flange. The perimeter build flange allows for theintroduction of another mid-substance metallic support plate, orsubstrate portions 50400, for example. In at least one embodiment, thesubstrate portions 50300, 50400 can be aligned in such a manner as tohave coupling plastic features (such as notches 50130, for example) thatprevent movement of the substrates 50300, 50400 within the body portion50100 while also preventing shear of the body portion 50100. In at leastone embodiment, the channel retainer 50000 is a sandwiched laminatecomprised of metal plates with 3D plastic printed coupling and assemblyfeatures. The metal plates are capable of bearing the load and stretchproperties and the 3D printed elements are configured to provide all thekeying, aligning, lateral support, and interlocking features withadjacent systems. 3D printing a channel retainer in this manner enablescomplex plastic interface features to be affixed to load bearingmetallic sub-frames within and around the 3D built part.

Further to the above, a steel stamped part could have a lateral flangebend in both ends for affixing to an elongate shaft and/or anarticulation joint of a surgical instrument. The flanges could be laidinto the 3D printer with the flanges away from the printing head path.The 3D build is then continued to form the rest of the channel retainer.As such, the lateral flange bends extend from the 3D printed channelretainer for attachment to the surgical instrument. In other words, thelateral flange bends are not overprinted with 3D printing material,extend from the 3D printed material, and are attachable to the surgicalinstrument.

Further to the above, other embodiments are envisioned with a 3D printedlaminate construction comprising a plastic body and metal substrates forvarious end effector components. For example, a staple cartridge, anelongate channel configured to receive a staple cartridge, and/or ananvil, could be constructed as a 3D printed laminate with plastic andmetallic materials. As such, embodiments are envisioned where other endeffector components utilize a plastic body for all of the keying andalignment features while the metal substrates bear the stretch anddeflection loads during operation.

Further to the above, with traditional insert molded parts creatingundercuts, interior voids, interior spaces, and/or features transverseto the parting line of the mold (.e. more than 3 degrees from theparting axis of the mold) may be difficult and costly to manufacture incertain instances. The 3D-printed plastic body discussed above, cancomprise undercuts, interior voids, and/or transverse alignment featuresfor connecting components, for example.

FIGS. 44 and 45 depict a surgical instrument 51000 comprising a firingbar support 51020, a firing bar 51010, and an over-molded sleeve 51030.The firing bar support 51020 comprises two lateral plates 51022, 51024positioned on both sides of the firing bar 51010. In the illustratedembodiment, the firing bar 51010 comprises a laminate firing barconstructed of several layers. Other embodiments are envisioned wherethe firing bar is a one-piece unitary structure. In any event, thefiring bar support 51020 prevents bucking of the firing bar 51010 duringfiring of the firing bar 51010 and/or articulation of the end effector51000. In certain instances, the firing bar support 51020 may beidentical to the firing bar support disclosed in U.S. patent applicationSer. No. 15/635,808 filed on Jun. 28, 2017, the entirety of which isincorporated by reference herein. Further, the firing bar support 51020comprises a flexible portion 51040 positioned in an articulation jointof the surgical instrument 51000. Specifically, FIG. 44 illustrates thesurgical instrument 51000 in an unarticulated orientation and FIG. 45illustrates the surgical instrument 51000 in an articulatedconfiguration.

The firing bar support 51020 is defined within the over-molded sleeve51030 that extends along the articulation joint of the surgicalinstrument 51000. In other words, the over-molded sleeve 51030encompasses and/or encapsulates the firing bar support 51020 therein. Inat least one embodiment, the over-molded sleeve 51030 may be a plastic3D printed material built around the firing bar support 51020 to embedand/or encapsulate the firing bar support 51020 therein. As such, theover-molded sleeve 51030 and the firing bar support 51020 comprise asubstantially unitary piece. Further, the unitary piece formed of theover-molded sleeve 51030 and the firing bar support 51030 comprises alongitudinal slot 51032 defined therein. The longitudinal slot 51032 isconfigured to receiving the firing bar 51010 to permit translation ofthe firing member 51010 therein.

FIG. 46 depicts an anvil 52000 for use with a surgical instrument, suchas those described herein. The anvil 52000 comprises a tissue contactingsurface 52020 and a longitudinal slot 52030 for receiving a portion of afiring member. The anvil 52000 further comprises an anvil slot 52040extending longitudinally along at least a portion of the anvil 52000. Inthe illustrated embodiment, the anvil slot 52040 is plus-shaped,however, other embodiments are envisioned where the anvil slot 52040 isT-shaped with a flat top portion. The reader will appreciate thatalternative geometries and shapes for the anvil slot 52040 arecontemplated. In any event, the anvil 52000 comprises a compliantportion 52050 extending longitudinally along at least a portion of theanvil slot 52040. In the illustrated embodiment, the compliant portion52050 is positioned around the perimeter of the anvil slot 52040 on allsides. However, other embodiments are envisioned where the compliantportion 52050 resides solely on a pair of anvil slot ledges 52060 of theanvil 52000.

In at least one embodiment, the compliant portion 52050 comprises a morecompressible material than the remainder of the anvil 52000. Forexample, the compliant portion 52050 can comprise a material that isless dense or softer (i.e., a smaller number on Mohs hardness scale)than the remainder of anvil 52000 material. In at least one embodiment,the compliant portion 52050 can be comprised of brass or bronze and theremainder of the anvil 52000 can be comprised of stainless steel. In anyevent, the upper pins or upper cam members of a firing member (i.e., anI-beam or E-beam) can ride along the compliant portion 52050 duringfiring. As such, the body of the anvil 52000 is more rigid with theanvil slot 52040 being softer and/or more compliant to facilitate moregive to the firing member during firing. Further, the compliant portion52050 may be smoother than the remainder of the anvil 52000 to furtherfacilitate sliding of the upper pins of the firing member within theanvil slot 52040.

Further to the above, the anvil 52000 may be constructed using 3Dprinting to position the compliant portion 52050 within the body of theanvil 52000. For example, the 3D printer could begin by building upstainless steel from the tissue contacting surface 52020 upward. The 3Dbuild could be stopped to insert the compliant member 52050, and thenthe build continued to encapsulate the compliant member 52050 within thestainless steel 3D print material of the anvil 52000. As such, thecompliant member 52050 and the anvil 52000 can be 3D printed to producea substantially unitary piece having two different materials. Otherembodiments are envisioned with more than two materials 3D printed intothe anvil 52000.

Various aspects of the subject matter described herein are set out inthe following examples.

Example 1—A firing member for use with a surgical instrument comprisingan anvil and an elongate channel configured to receive a staplecartridge. The firing member comprises a body portion configured to bedriven through a firing stroke, a first cam member extending laterallyfrom the body portion and configured to cammingly engage the anvilduring the firing stroke, a second cam member extending laterally fromthe body portion and configured to cammingly engage the elongate channelduring the firing stroke, and a lattice portion comprising a pattern ofspaces formed in the firing member. The lattice portion is configured toflex more readily from a load during the firing stroke than adjacentportions of the firing member.

Example 2—The firing member of Example 1, wherein the lattice portion ispositioned intermediate the first cam member and the second cam member.

Example 3—The firing member of Examples 1 or 2, further comprising alongitudinal slot extending longitudinally through the firing member,wherein the longitudinal slot bifurcates the lattice portion into afirst portion on a first side of the longitudinal slot and a secondportion on a second side of the longitudinal slot, and wherein thelattice portion is configured to deflect in opposing directions onopposite sides of the longitudinal slot.

Example 4—The firing member of Example 3, wherein the pattern of spacescomprises a first plurality of slots in the first portion and a secondplurality of slots in the second portion.

Example 5—The firing member of Example 4, wherein the first plurality ofslots are oriented in a first direction, and wherein the secondplurality of slots are oriented in a second direction opposite the firstdirection.

Example 6—The firing member of Examples 4 or 5, wherein the firstplurality of slots are parallel to one another, and wherein the secondplurality of slots are parallel to one another.

Example 7—The firing member of Examples 1, 2, 3, 4, 5, or 6, wherein thelattice portion connects at least a portion of the first cam member tothe body portion.

Example 8—The firing member of Examples 1, 2, 3, 4, 5, 6, or 7, whereinthe pattern of spaces define a plurality of arcuate bars connecting thefirst cam member and the body portion.

Example 9—The firing member of Example 8, wherein the plurality ofarcuate bars are arranged in an array.

Example 10—The firing member of Examples 1, 2, 3, 4, 5, 6, 7, 8, or 9,wherein the pattern of spaces comprises an array of crisscrossingdiagonal slots.

Example 11—The firing member of Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, or10, wherein the lattice portion is less rigid than the first cam memberand the body portion.

Example 12—An end effector comprising an anvil, an elongate channelconfigured to receive a staple cartridge, and a firing member. Thefiring member comprises a body portion, a first cam member extendinglaterally from the body portion and configured to cammingly engage theanvil during a firing stroke of the firing member, a second cam memberextending laterally from the body portion and configured to camminglyengage the elongate channel during the firing stroke, and a flexibleportion positioned intermediate the first cam member and the bodyportion. The flexible portion comprises a three-dimensional latticecomprising an array of cavities.

Example 13—The end effector of Example 12, wherein the array of cavitiesdefine a plurality of arcuate bars.

Example 14—The end effector of Examples 12 or 13, wherein the flexibleportion comprises a first rigidity, wherein the body portion and thefirst cam member comprise a second rigidity, and wherein the firstrigidity and the second rigidity are different.

Example 15—A firing member for use with a surgical instrument comprisinga first jaw and a second jaw. The firing member comprises a body portionconfigured to move longitudinally through a firing stroke, a first cammember extending laterally from the body portion and configured tocammingly engage the first jaw during the firing stroke, a second cammember extending laterally from the body portion and configured tocammingly engage the second jaw during the firing stroke, and a lowdensity portion comprising a flexible lattice configured to flex morereadily from a load during the firing stroke than adjacent portions ofthe firing member.

Example 16—The firing member of Example 15, wherein the flexible latticedeflects a first amount when the first cam member is under the load,wherein the body portion adjacent the flexible lattice deflects a secondamount when the first cam member is under the load, and wherein thefirst amount is greater than the second amount.

Example 17—The firing member of Examples 15 or 16, wherein the bodyportion comprises a first rigidity, wherein the flexible latticecomprises a second rigidity, and wherein the first rigidity and thesecond rigidity are different.

Example 18—The firing member of Examples 15, 16, or 17, wherein theflexible lattice comprises a plurality of slots arranged in a patternand defined in the body portion.

Example 19—The firing member of Examples 15, 16, 17, or 18, wherein thebody portion comprises a first infill percentage, wherein the lowdensity portion comprises a second infill percentage, and wherein thefirst infill percentage and the second infill percentage are different.

Example 20—The firing member of Examples 15, 16, 17, 18, or 19, furthercomprising a longitudinal slot extending longitudinally through thefiring member, wherein the longitudinal slot bifurcates the flexiblelattice into a first portion on a first side of the longitudinal slotand a second portion on a second side of the longitudinal slot.

Example 21—The firing member of Example 20, wherein the first portioncomprises a plurality of slots oriented in a first direction and thesecond portion comprises a plurality of slots oriented in a seconddirection that is opposite the first direction.

Example 22—A firing member for use with a surgical instrument comprisingan anvil and an elongate channel configured to receive a staplecartridge, wherein the firing member comprises a body portion configuredto be driven through a firing stroke, a first cam member extendinglaterally from the body portion and configured to cammingly engage theanvil during the firing stroke, a second cam member extending laterallyfrom the body portion and configured to cammingly engage the elongatechannel during the firing stroke, and a flexible portion. The flexibleportion comprises a pattern of spaces formed in the firing member. Theflexible portion is configured to flex more readily from a load duringthe firing stroke than adjacent less flexible portions of the firingmember. The flexible portion is the same material as the adjacent lessflexible portions.

Example 23—A channel retainer for use with a surgical device. Thechannel retainer is positionable between a handle and an end effector ofthe surgical device. The channel retainer comprises a proximal end, adistal end, a plastic body extending from the proximal end to the distalend, a first metal substrate positioned within the plastic body, and asecond metal substrate positioned within the plastic body. The firstmetal substrate comprises a lateral flange. The second metal substratecomprises an opening. The lateral flange is positioned within theopening to operably connect the first metal substrate and the secondmetal substrate within the plastic body.

Example 24—The channel retainer of Example 23, wherein the first metalsubstrate is positioned at the proximal end of the channel retainer, andwherein the proximal end of the channel retainer is configured to beattached to the handle of the surgical device.

Example 25—The channel retainer of Examples 23 or 24, wherein theplastic body comprises an alignment notch, and wherein the first metalsubstrate comprises another lateral flange embedded in the plastic bodyproximal to the alignment notch.

Example 26—The channel retainer of Examples 23, 24, or 25, wherein atleast one of the first metal substrate and the second metal substratecomprises a stamped metal component.

Example 27—The channel retainer of Examples 23, 24, 25, or 26, whereinthe plastic body is printed on the first metal substrate and the secondmetal substrate.

Example 28—The channel retainer of Examples 23, 24, 25, 26, or 27,wherein the plastic body comprises one of a group consisting of a keyingfeature, an alignment feature, and an interlocking feature forconnection with the surgical device.

Example 29—The channel retainer of Examples 23, 24, 25, 26, 27, or 28,wherein at least one of the first metal substrate and the second metalsubstrate comprises a flexible circuit board.

Example 30—A channel retainer for use with a surgical device. Thechannel retainer comprises a proximal end, a distal end, a first metalsubstrate, a second metal substrate interlocking with the first metalsubstrate, and a plastic portion extending from the proximal end to thedistal end. The plastic portion is built around the first metalsubstrate and the second metal substrate.

Example 31—The channel retainer of Example 30, wherein the first metalsubstrate comprises a flange embedded in an alignment portion of theplastic portion, and wherein the alignment portion is configured toattach the plastic portion to the surgical device.

Example 32—The channel retainer of Examples 30 or 31, wherein theplastic portion comprises an alignment notch, and wherein the firstmetal substrate comprises a lateral flange embedded in the plasticportion proximal to the alignment notch.

Example 33—The channel retainer of Examples 30, 31, or 32, wherein atleast one of the first metal substrate and the second metal substratecomprises a stamped metal component.

Example 34—The channel retainer of Examples 30, 31, 32, or 33, whereinthe plastic portion is printed on the first metal substrate and thesecond metal substrate.

Example 35—The channel retainer of Examples 30, 31, 32, 33, or 34,wherein the plastic portion comprises one of a group consisting of akeying feature, an aligning feature, and an interlocking feature forconnection with the surgical device.

Example 36—The channel retainer of Examples 30, 31, 32, 33, 34, or 35,wherein at least one of the first metal substrate and the second metalsubstrate comprises a flexible circuit board.

Example 37—An end effector component for use with a surgical staplingdevice. The end effector component comprises a plastic body comprisingalignment features. The end effector component further comprises a firstmetal substrate at least partially surrounded by the plastic body. Theend effector component further comprises a second metal substrate atleast partially surrounded by the plastic body. The first metalsubstrate and the second metal substrate comprise substrate interlockingfeatures embedded within the plastic body.

Example 38—The end effector component of Example 37, wherein the firstmetal substrate comprise a lateral flange, wherein the second metalsubstrate comprises an opening, and wherein the lateral flange ispositioned within the opening and surrounded by the plastic body.

Example 39—The end effector component of Examples 37 or 38, wherein thealignment features comprise notches at a proximal and a distal end ofthe plastic body, and wherein the notches facilitate attachment andalignment of the end effector component to a handle and an end effectorof the surgical stapling device.

Example 40—The end effector component of Examples 37, 38, or 39, whereinthe end effector component comprises an elongate channel configured toreceive a staple cartridge.

Example 41—The end effector component of Examples 37, 38, 39, or 40,wherein at least one of the first metal substrate and the second metalsubstrate comprises a flexible circuit board.

Example 42—The end effector component of Examples 37, 38, 39, 40, or 41wherein the plastic body comprises an interior void, and wherein theinterior void is completely surrounded by the plastic body.

Example 43—The end effector component of Examples 37, 38, 39, 40, 41, or42, wherein the plastic body comprises an undercut.

Many of the surgical instrument systems described herein are motivatedby an electric motor; however, the surgical instrument systems describedherein can be motivated in any suitable manner. In various instances,the surgical instrument systems described herein can be motivated by amanually-operated trigger, for example. In certain instances, the motorsdisclosed herein may comprise a portion or portions of a roboticallycontrolled system. Moreover, any of the end effectors and/or toolassemblies disclosed herein can be utilized with a robotic surgicalinstrument system. U.S. patent application Ser. No. 13/118,241, entitledSURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS, now U.S. Pat. No. 9,072,535, for example, disclosesseveral examples of a robotic surgical instrument system in greaterdetail.

The surgical instrument systems described herein have been described inconnection with the deployment and deformation of staples; however, theembodiments described herein are not so limited. Various embodiments areenvisioned which deploy fasteners other than staples, such as clamps ortacks, for example. Moreover, various embodiments are envisioned whichutilize any suitable means for sealing tissue. For instance, an endeffector in accordance with various embodiments can comprise electrodesconfigured to heat and seal the tissue. Also, for instance, an endeffector in accordance with certain embodiments can apply vibrationalenergy to seal the tissue.

The entire disclosures of:

-   -   U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC        DEVICE, which issued on April 4, 1995;    -   U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT        HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, which        issued on Feb. 21, 2006;    -   U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING        AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK, which        issued on Sep. 9, 2008;    -   U.S. Pat. No. 7,464,849, entitled ELECTRO-MECHANICAL SURGICAL        INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS,        which issued on Dec. 16, 2008;    -   U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING AN        ARTICULATING END EFFECTOR, which issued on Mar. 2, 2010;    -   U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS,        which issued on Jul. 13, 2010;    -   U.S. Pat. No. 8,393,514, entitled SELECTIVELY ORIENTABLE        IMPLANTABLE FASTENER CARTRIDGE, which issued on Mar. 12, 2013;    -   U.S. patent application Ser. No. 11/343,803, entitled SURGICAL        INSTRUMENT HAVING RECORDING CAPABILITIES, now U.S. Pat. No.        7,845,537;    -   U.S. patent application Ser. No. 12/031,573, entitled SURGICAL        CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES, filed        Feb. 14, 2008;    -   U.S. patent application Ser. No. 12/031,873, entitled END        EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, filed        Feb. 15, 2008, now U.S. Pat. No. 7,980,443;    -   U.S. patent application Ser. No. 12/235,782, entitled        MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT, now U.S. Pat. No.        8,210,411;    -   U.S. patent application Ser. No. 12/249,117, entitled POWERED        SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY        RETRACTABLE FIRING SYSTEM, now U.S. Pat. No. 8,608,045;    -   U.S. patent application Ser. No. 12/647,100, entitled        MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR        DIRECTIONAL CONTROL ASSEMBLY, filed Dec. 24, 2009, now U.S. Pat.        No. 8,220,688;    -   U.S. patent application Ser. No. 12/893,461, entitled STAPLE        CARTRIDGE, filed Sep. 29, 2012, now U.S. Pat. No. 8,733,613;    -   U.S. patent application Ser. No. 13/036,647, entitled SURGICAL        STAPLING INSTRUMENT, filed Feb. 28, 2011, now U.S. Pat. No.        8,561,870;    -   U.S. patent application Ser. No. 13/118,241, entitled SURGICAL        STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT        ARRANGEMENTS, now U.S. Pat. No. 9,072,535;    -   U.S. patent application Ser. No. 13/524,049, entitled        ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE,        filed on Jun. 15, 2012, now U.S. Pat. No. 9,101,358;    -   U.S. patent application Ser. No. 13/800,025, entitled STAPLE        CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13,        2013, now U.S. Pat. No. 9,345,481;    -   U.S. patent application Ser. No. 13/800,067, entitled STAPLE        CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13,        2013, now U.S. Patent Application Publication No. 2014/0263552;    -   U.S. Patent Application Publication No. 2007/0175955, entitled        SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER        LOCKING MECHANISM, filed Jan. 31, 2006; and    -   U.S. Patent Application Publication No. 2010/0264194, entitled        SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR,        filed Apr. 22, 2010, now U.S. Pat. No. 8,308,040, are hereby        incorporated by reference herein.

Although various devices have been described herein in connection withcertain embodiments, modifications and variations to those embodimentsmay be implemented. Particular features, structures, or characteristicsmay be combined in any suitable manner in one or more embodiments. Thus,the particular features, structures, or characteristics illustrated ordescribed in connection with one embodiment may be combined in whole orin part, with the features, structures or characteristics of one or moreother embodiments without limitation. Also, where materials aredisclosed for certain components, other materials may be used.Furthermore, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Theforegoing description and following claims are intended to cover allsuch modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, a device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the stepsincluding, but not limited to, the disassembly of the device, followedby cleaning or replacement of particular pieces of the device, andsubsequent reassembly of the device. In particular, a reconditioningfacility and/or surgical team can disassemble a device and, aftercleaning and/or replacing particular parts of the device, the device canbe reassembled for subsequent use. Those skilled in the art willappreciate that reconditioning of a device can utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

The devices disclosed herein may be processed before surgery. First, anew or used instrument may be obtained and, when necessary, cleaned. Theinstrument may then be sterilized. In one sterilization technique, theinstrument is placed in a closed and sealed container, such as a plasticor TYVEK bag. The container and instrument may then be placed in a fieldof radiation that can penetrate the container, such as gamma radiation,x-rays, and/or high-energy electrons. The radiation may kill bacteria onthe instrument and in the container. The sterilized instrument may thenbe stored in the sterile container. The sealed container may keep theinstrument sterile until it is opened in a medical facility. A devicemay also be sterilized using any other technique known in the art,including but not limited to beta radiation, gamma radiation, ethyleneoxide, plasma peroxide, and/or steam.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdo not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A channel retainer for use with a surgicaldevice, wherein the channel retainer is positionable between a handleand an end effector of the surgical device, and wherein the channelretainer comprises: a proximal end; a distal end; a plastic bodyextending from the proximal end to the distal end; a first metalsubstrate positioned within the plastic body, wherein the first metalsubstrate comprises a lateral flange; and a second metal substratepositioned within the plastic body, wherein the second metal substratecomprises an opening, and wherein the lateral flange is positionedwithin the opening to operably connect the first metal substrate and thesecond metal substrate within the plastic body.
 2. The channel retainerof claim 1, wherein the first metal substrate is positioned at theproximal end of the channel retainer, and wherein the proximal end ofthe channel retainer is configured to be attached to the handle of thesurgical device.
 3. The channel retainer of claim 1, wherein the plasticbody comprises an alignment notch, and wherein the first metal substratecomprises another lateral flange embedded in the plastic body proximalto the alignment notch.
 4. The channel retainer of claim 1, wherein atleast one of the first metal substrate and the second metal substratecomprises a stamped metal component.
 5. The channel retainer of claim 1,wherein the plastic body is printed on the first metal substrate and thesecond metal substrate.
 6. The channel retainer of claim 1, wherein theplastic body comprises one of a group consisting of a keying feature, analignment feature, and an interlocking feature for connection with thesurgical device.
 7. The channel retainer of claim 1, wherein at leastone of the first metal substrate and the second metal substratecomprises a flexible circuit board.
 8. A channel retainer for use with asurgical device, wherein the channel retainer comprises: a proximal end;a distal end; a first metal substrate; a second metal substrateinterlocking with the first metal substrate; and a plastic portionextending from the proximal end to the distal end, wherein the plasticportion is built around the first metal substrate and the second metalsubstrate.
 9. The channel retainer of claim 8, wherein the first metalsubstrate comprises a flange embedded in an alignment portion of theplastic portion, and wherein the alignment portion is configured toattach the plastic portion to the surgical device.
 10. The channelretainer of claim 8, wherein the plastic portion comprises an alignmentnotch, and wherein the first metal substrate comprises a lateral flangeembedded in the plastic portion proximal to the alignment notch.
 11. Thechannel retainer of claim 8, wherein at least one of the first metalsubstrate and the second metal substrate comprises a stamped metalcomponent.
 12. The channel retainer of claim 8, wherein the plasticportion is printed on the first metal substrate and the second metalsubstrate.
 13. The channel retainer of claim 8, wherein the plasticportion comprises one of a group consisting of a keying feature, analigning feature, and an interlocking feature for connection with thesurgical device.
 14. The channel retainer of claim 8, wherein at leastone of the first metal substrate and the second metal substratecomprises a flexible circuit board.
 15. An end effector component foruse with a surgical stapling device, wherein the end effector componentcomprises: a plastic body comprising alignment features; a first metalsubstrate at least partially surrounded by the plastic body; and asecond metal substrate at least partially surrounded by the plasticbody, wherein the first metal substrate and the second metal substratecomprise substrate interlocking features embedded within the plasticbody.
 16. The end effector component of claim 15, wherein the firstmetal substrate comprise a lateral flange, wherein the second metalsubstrate comprises an opening, and wherein the lateral flange ispositioned within the opening and surrounded by the plastic body. 17.The end effector component of claim 15, wherein the alignment featurescomprise notches at a proximal and a distal end of the plastic body, andwherein the notches facilitate attachment and alignment of the endeffector component to a handle and an end effector of the surgicalstapling device.
 18. The end effector component of claim 15, wherein theend effector component comprises an elongate channel configured toreceive a staple cartridge.
 19. The end effector component of claim 15,wherein at least one of the first metal substrate and the second metalsubstrate comprises a flexible circuit board.
 20. The end effectorcomponent of claim 15, wherein the plastic body comprises an interiorvoid, and wherein the interior void is completely surrounded by theplastic body.
 21. The end effector component of claim 15, wherein theplastic body comprises an undercut.